Reported trial results for Tuberculosis

101 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT05630872 · results posted 20 July 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 adults living with HIV who had also been newly diagnosed with drug-sensitive tuberculosis (TB) and were not yet on HIV treatment. The trial was measuring how a HIV medication called dolutegravir (DTG) behaves in the body when taken alongside a TB treatment regimen that includes a drug called rifapentine (plus isoniazid, pyrazinamide, and ethambutol). Twenty-eight of the 30 participants completed the study, and two did not complete it. The trial was focused on pharmacokinetics — that is, tracking how the medication moves through the body, including how much of it remains in the bloodstream at its lowest point between doses. The reported data shows that the main result — a computer-simulated estimate of the lowest level of dolutegravir remaining in the blood (at the 5th percentile, meaning the lowest range across a simulated population of 10,000 people) when taken twice daily alongside rifapentine — was 0.30 micrograms per millilitre (µg/mL). For the secondary measurements, the reported lowest blood level of dolutegravir (Cmin) was 0.70 µg/mL in one condition and 0.82 µg/mL in another. The reported peak blood level (Cmax) was 2.72 µg/mL and 3.60 µg/mL respectively. The reported total drug exposure over 24 hours (a measure called AUC, which reflects the overall amount of drug in the blood across a day) was 37.0 and 47.3 µg·h/mL. The rate at which the body cleared the drug was reported as 2.70 and 1.06 litres per hour, and the time it took for the drug level to reduce by half was reported as 4.51 hours and 10.10 hours across the two conditions measured. The reported data shows two sets of figures for most secondary outcomes, which likely reflect measurements taken under different conditions (for example, with and without rifapentine), though the labelling of these two conditions was not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03266003 · results posted 2 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT03266003) enrolled 211 people in total — 109 in one group and 102 in the other. It was a crossover study, meaning each person tried both methods of directly observed therapy (DOT) for tuberculosis (TB) medication: in-person DOT (ipDOT), where a staff member watches the person take their medication face-to-face, and electronic DOT (eDOT), where the person records a video of themselves taking their medication for staff to review. The trial's main goal was to measure how many medication doses were actually observed by staff under each method. The reported data shows that across the two main analyses used, the number of doses observed differed between the two methods. In one analysis, 2,783 doses were observed under in-person DOT compared with 2,913 doses under electronic DOT. In a second analysis approach, 2,601 doses were observed under in-person DOT compared with 3,091 under electronic DOT. For one of the secondary measures — the number of doses that were *not* directly observed by staff — the reported data shows 798 missed doses under in-person DOT and 2,794 missed doses under electronic DOT. For another secondary measure looking at how long it took from a participant first noticing a possible medication side effect to receiving medical attention, the reported data shows a median of 1.0 day for both methods. Two additional pre-specified outcomes relating to participant characteristics and overall treatment outcomes did not have numerical results reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05413551 · results posted 15 June 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 78 people in total, split into three groups based on how quickly their bodies process a tuberculosis antibiotic called isoniazid: 10 "rapid acetylators," 34 "intermediate acetylators," and 34 "slow acetylators." These labels describe a genetic difference in how fast a person breaks down the drug. The trial was measuring how isoniazid moves through the body — specifically how much of the drug is present in the blood over time, how quickly the body clears it, and what peak levels are reached. By the end of the study, 9 rapid, 27 intermediate, and 26 slow acetylators had completed the trial. The reported data shows the main measurements (called "primary outcomes") were the total drug exposure over 24 hours and how fast the body cleared the drug. Total exposure (a measure of how much drug the body was exposed to across a full day) was reported as 24.4 and 40.7 mg·h/L for rapid acetylators, 31.0 and 30.6 mg·h/L for intermediate acetylators, and 57.6 and 18.3 mg·h/L for slow acetylators — with the two figures for each group appearing to reflect measurements taken at two different time points (Days 7 and 14). For how quickly the body cleared the drug, the reported figures were 38.5 litres per hour for rapid acetylators, 30.3 for intermediate acetylators, and 17.6 for slow acetylators, suggesting the groups differed in this measurement. The reported data also shows secondary measurements including the highest drug level reached in the blood (the "peak concentration") and the level still present at 24 hours after dosing. Peak concentrations were reported as ranging from around 3.13 to 12.8 micrograms per millilitre depending on the group and time point, while the amount of drug still in the blood at 24 hours was much lower across all groups, ranging from 0.0116 to 0.137 micrograms per millilitre. The data was not reported in a way that allows a simple direct comparison between time points for all measures, so some figures should be interpreted cautiously. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05327803 · results posted 10 June 2026

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called epetraborole, given alongside an existing background treatment regimen (referred to as OBR), compared with a placebo (a dummy treatment) also given with OBR. The trial ran in two stages — Phase 2 and Phase 3. In Phase 2, 39 people were assigned to epetraborole plus OBR and 41 to placebo plus OBR, with 35 and 34 respectively completing that phase. In Phase 3, 66 people started in the epetraborole plus OBR group and 31 in the placebo plus OBR group, with 52 and 22 completing it. The trial was measuring things like side effects, symptom changes reported by patients themselves, and whether the bacterial infection (a type called MAC) cleared from patients' sputum (mucus coughed up from the lungs). The reported data shows that in Phase 2, when it came to side effects, 37 out of 39 people in the epetraborole group and 35 out of 41 in the placebo group reported a treatment-related adverse event (an unwanted health event that occurred during the trial). For the main symptom measure — whether patients felt at least one symptom improved without any others getting worse by six months — 15 out of 39 in the epetraborole group and 10 out of 41 in the placebo group met that measure. Regarding whether the bacterial infection cleared from sputum samples over three consecutive months by Month 6, 5 out of 39 in the epetraborole group and 4 out of 41 in the placebo group reached that point. The reported data also shows results from two quality-of-life questionnaires used in Phase 2. On a breathing-related quality-of-life scale (scored 0–100, where higher means better), the epetraborole group's average score changed by +7.20 points from the start of the trial to Month 6, while the placebo group's changed by +0.30 points. On a separate symptom questionnaire (also 0–100, higher meaning better), the epetraborole group's average score changed by +6.20 points and the placebo group's by +0.83 points. For one secondary measure — a reduction in the amount of bacteria detected in sputum samples by Month 3 or 6 — 9 out of 39 in the epetraborole group and 16 out of 41 in the placebo group met that measure; the Phase 3 outcome data was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00164281 · results posted 27 May 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,995 participants in total — 1,006 in the continuous isoniazid group and 989 in the limited (placebo) isoniazid group. The trial was measuring whether taking isoniazid (an antibiotic used against tuberculosis) continuously over time made a difference compared to a shorter, limited course, in people followed up over 36 months. The main thing researchers tracked was how many participants developed tuberculosis (TB). They also tracked how many participants died from any cause, and a combined count of those who either developed TB or died. The reported data shows that, for the primary outcome of new TB cases, 20 participants in the continuous isoniazid group developed TB compared to 34 in the limited (placebo) isoniazid group. For deaths from any cause over the 36-month follow-up, the numbers were very similar — 39 deaths in the continuous isoniazid group and 38 deaths in the limited isoniazid group. When TB cases and deaths were counted together as a combined outcome, the reported figures were 59 participants in the continuous isoniazid group and 72 in the limited isoniazid group. It is worth noting that not all participants completed the study — 155 in the continuous group and 162 in the limited group did not finish. The reported data shows these figures as they were submitted to the clinical trial registry, but this summary does not draw conclusions about whether one approach is better, safer, or more suitable than another for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05007821 · results posted 1 May 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT05007821) enrolled 138 people in total — 69 in Arm A and 69 in Arm B. The trial was looking at treatments for tuberculosis (TB), and it measured two main things: how quickly participants' sputum (mucus) samples stopped showing signs of TB bacteria over 26 weeks, and how many participants permanently stopped taking at least one of their TB medicines due to side effects, intolerance, or death. A secondary focus was the proportion of participants whose sputum samples had cleared of TB bacteria at specific points in time (weeks 8, 16, and 26). It is worth noting that the reported data shows zero participants were recorded as having "completed" the study in the formal milestone tracking, and all 138 were listed as "not completed" — no further explanation for this was provided in the data. The reported data shows that, for the primary outcome of time to bacterial clearance, the median time was 8 weeks for Arm A and 12 weeks for Arm B. For the other primary outcome — the proportion of participants who permanently stopped at least one TB medicine — the reported figures were approximately 15.3% (roughly 1 in 7) in Arm A and 12.0% (roughly 1 in 8) in Arm B. For the secondary outcomes tracking bacterial clearance at set time points: by week 8, approximately 60.7% of Arm A and 50.5% of Arm B had cleared the bacteria; by week 16, those figures were approximately 96.2% and 90.7% respectively; and by week 26, approximately 96.7% in Arm A and 92.0% in Arm B. The week 38 data was not yet reported at the time of submission. The reported data does not include results for the week 38 secondary outcome, as that data was noted to be pending the study's formal completion date. No figures for that time point were provided, so none can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03512249 · results posted 24 February 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 831 adults — 415 in the H56:IC31 vaccine group and 416 in the placebo group. The trial was testing a tuberculosis (TB) vaccine called H56:IC31 in people who had already been treated for TB, to see whether it could reduce the chances of TB coming back, either as a return of the same infection (relapse) or a new infection with a different strain (reinfection). Participants were HIV-negative and had recently completed most of their TB treatment. By the end of the trial, 358 people in the vaccine group and 384 in the placebo group had completed the study. The reported data shows that, for the main outcome — confirmed TB coming back — 23 out of 377 participants in the vaccine group had a recurrence, compared with 14 out of 392 in the placebo group. For the secondary breakdown, 12 people in the vaccine group and 6 in the placebo group were recorded as having a relapse (same TB strain returning), while 8 in the vaccine group and 7 in the placebo group were recorded as having a reinfection (a different TB strain). Regarding side effects tracked in the 14 days after each vaccination, 266 people in the vaccine group and 228 in the placebo group reported at least one adverse event (an unwanted symptom or health event) after their first dose, and 212 versus 161 respectively after their second dose. Serious adverse events — meaning more significant health events requiring medical attention — were reported by 14 people in the vaccine group and 12 in the placebo group across the whole trial period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05027958 · results posted 6 November 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 17 healthy volunteers in total — 7 people who had latent tuberculosis infection (LTBI, meaning the TB bacteria are present in the body but not causing active illness) and 10 people who did not have LTBI. The trial was measuring how the immune system responds in the lungs when a small amount of a TB-related protein (called tuberculin PPD) is placed directly into the airway. Specifically, it looked at a type of immune cell called CD4 T cells, and also used a special full-body scan (PET-CT) to look at activity levels in lung tissue and nearby lymph nodes. Of the 17 who started, 8 completed the study — 4 from each group, and the remaining 9 did not complete it. The reported data shows that, when measuring the proportion of CD4 T cells responding to the TB protein in blood samples, the LTBI group had a median (middle value) of 5.26% antigen-specific T cells, compared with 0.725% in the non-LTBI group. In lung fluid samples, the reported figures were higher — 29.9% in the LTBI group versus 2.92% in the non-LTBI group. For the PET-CT scan results, the reported data shows activity levels (called Standard Uptake Values, or SUVs — a measure of how much a scanner signal is detected in a given area) across several lung and lymph node measurements. In the LTBI group, these SUV figures ranged from approximately 0.498 to 2.003, while in the non-LTBI group they ranged from approximately 0.388 to 1.693, across the various measurement points reported. It is worth noting that the numbers above come from a small group of participants, and the trial's data as submitted does not include fuller context such as whether the differences between groups were considered statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04311502 · results posted 27 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04311502) enrolled 104 people across three groups: 58 in the experimental treatment arm, 31 in the standard-of-care arm, and 15 in a smaller subgroup focused on how the body processes the drug (called a pharmacokinetics, or "PK," subgroup). The trial was measuring two main things: how quickly participants' sputum (mucus coughed up from the lungs) stopped showing signs of tuberculosis (TB) bacteria in laboratory tests, and how many participants experienced serious unwanted health events (called adverse events, graded on a scale of 1–5, with grade 3 being "severe") during the study. The reported data shows that, on average, participants in the experimental arm reached the point where their sputum tests were consistently clear of TB bacteria in about 6 weeks, compared with about 8 weeks in the standard-of-care arm. For the safety measure, the reported data shows that 26 participants in the experimental arm and 5 in the standard-of-care arm experienced at least one serious (grade 3 or higher) adverse event that was worse than their starting condition. Regarding longer-term outcomes at 65 weeks, the proportion of participants recorded as having a favourable outcome (meaning their infection appeared cleared and they had no ongoing TB signs) was reported as approximately 50% in the experimental arm and 76% in the standard-of-care arm, using one definition, and approximately 49% versus 74% using a slightly stricter definition. The reported data also shows that a heart rhythm measurement (called QTcF, a way of checking the heart's electrical activity) was somewhat higher in the experimental arm than the standard-of-care arm at multiple time points, though the specific meaning of this difference was not explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04556981 · results posted 17 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04556981) involved 402 participants in total — 202 received the M72/AS01E candidate tuberculosis vaccine and 200 received a placebo (an inactive injection). The trial was primarily measuring the number of participants who experienced certain health events after each of their two injections, including both "solicited" events (symptoms participants were specifically asked to record in a diary, such as pain at the injection site, fever, headache, fatigue, and muscle aches) and "unsolicited" events (any other health events noticed in the following weeks). The trial also tracked serious health events and a specific category of immune-related conditions. The reported data shows that, in the seven days after the first injection, 155 out of 202 people in the M72/AS01E group recorded solicited symptoms, compared with 49 out of 200 in the placebo group; local injection-site reactions specifically were reported by 132 (M72/AS01E) versus 109 (placebo) participants. After the second injection, 147 in the M72/AS01E group and 29 in the placebo group reported solicited symptoms, with local reactions reported by 134 versus 83 participants respectively. For unsolicited health events in the 28 days after each dose, the numbers were similar between groups: 67 versus 67 after dose one, and 53 versus 41 after dose two. Serious health events were reported by 4 participants in the M72/AS01E group and 5 in the placebo group. The reported data shows that zero participants in either group were recorded as experiencing potential immune-mediated diseases (conditions where the immune system may be involved). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT06041919 · results posted 15 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT06041919) enrolled 20 participants in total — 15 in the active treatment group (Group 1) and 5 in a control group (Group 2). Groups 3, 4, and 5 were listed but had no participants recorded. Of those who started, 14 active-group participants and 4 control-group participants completed the study. The trial was measuring something called "Early Bactericidal Activity" — essentially, how quickly the number of live tuberculosis bacteria in participants' sputum (mucus coughed up from the lungs) changed over time after receiving inhaled RESP301, an investigational treatment for tuberculosis. The reported data shows that the primary outcome tracked bacteria levels using a measure called "Time to Positivity" (TTP, measured in hours — a higher number generally suggests fewer bacteria detected). Over the periods measured (days 0–2, 0–7, 0–14, 0–15, and days 14–15), the active group's TTP values were reported as 3.5, 2.0, 2.5, 6.2, and 7.5 hours respectively, while the control group's corresponding values were 63.5, 140.2, 167.8, 225, and 2.0 hours. For the secondary bacteria measure (colony-forming units, a direct count of live bacteria on a logarithmic scale), the active group's values across the same time periods were 0.3, 0.2, 0.4, 0.3, and 0.0, while the control group's were −0.9, −1.2, −2.9, −2.4, and 0.1. The reported data also recorded the number of "treatment-emergent adverse events" (unexpected health events occurring during the trial): 38 total events were recorded in the active group and 7 in the control group, with 13 versus 2 considered possibly related to the study treatment, and 2 versus 0 classified as serious. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04703075 · results posted 19 June 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04703075) enrolled 500 adults and adolescents who did not have HIV but were considered at increased risk of tuberculosis (TB). Participants were split into two groups: 249 people received a treatment referred to as "1HP" (Arm A) and 251 received a treatment referred to as "3HP" (Arm B). The trial was measuring two main things — how many people in each group completed their treatment as directed (taking more than 90% of their doses), and how many experienced notable side effects or stopped treatment early because of side effects. The reported data shows that, when it came to completing treatment with more than 90% of doses taken, 223 out of 249 participants in the 1HP group and 211 out of 251 in the 3HP group reached this level of adherence. Regarding side effects or stopping treatment early, the reported data shows that 40 participants in the 1HP group and 26 participants in the 3HP group either experienced a moderate-to-severe targeted side effect (graded as "Grade 2 or more," meaning side effects considered at least moderately significant) or discontinued treatment due to any side effect. Overall, the trial tracked how these two groups compared across those two measures. It is worth noting that the data as submitted does not include any further breakdown or statistical comparisons beyond the participant counts described above, so no additional figures are available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04152161 · results posted 19 June 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 919 people in the BCG vaccine group and 917 people in the placebo (dummy injection) group — a total of 1,836 participants. The trial was measuring whether receiving the BCG vaccine (a well-known tuberculosis vaccine) affected the likelihood of people testing positive for tuberculosis infection over time. This was tracked using a blood test called QuantiFERON-TB Gold Plus (QFT), which detects signs that the immune system has been exposed to tuberculosis bacteria. The researchers were specifically looking for "sustained conversion" — meaning a person's test changed from negative to positive and stayed positive at both three and six months after that change. The reported data shows that for the primary outcome — sustained conversion to a positive tuberculosis blood test at any point during the study — 82 out of 919 participants in the BCG group and 78 out of 917 participants in the placebo group recorded this result. For the secondary outcomes looking at sustained conversion measured at the 36-month and 48-month follow-up points (or at the time participants left the study early), the numbers were similarly close: 74 BCG versus 73 placebo at 36 months, and 82 BCG versus 78 placebo at 48 months. Regarding reported health events after vaccination, 754 participants in the BCG group and 381 in the placebo group reported pre-specified ("solicited") side effects in the first 7 days; 371 BCG and 314 placebo participants reported serious versions of those solicited events. Within 28 days, 185 BCG and 117 placebo participants reported other ("unsolicited") health events. Serious adverse events — meaning significant medical events such as hospitalisation — were reported by 3 participants in each group. It is worth noting that only around 110–111 participants per group formally completed the full study out of the roughly 919–917 who started, and the reasons for the large number not completing were not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04221789 · results posted 21 May 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04221789) involved 555 people being treated for tuberculosis (TB). Participants were split into two groups: 277 people used something called a "TB Treatment Assistant" (a digital or app-based tool to support their treatment), and 278 people were in a control group, meaning they received the usual care without this tool. The trial was measuring how many people successfully completed their six-month TB treatment course, and how many stopped taking their treatment early. The reported data shows that, when it came to completing treatment successfully — defined as finishing the full six months of treatment and/or showing the infection had cleared — 208 out of 277 people in the TB Treatment Assistant group and 201 out of 278 people in the control group met this outcome. For the second measure, which looked at how many people abandoned their treatment for at least two months, the reported data shows 44 people in the TB Treatment Assistant group and 66 people in the control group stopped treatment for that length of time. It is worth noting that more people in the TB Treatment Assistant group did not complete the study overall (22 people, compared to 8 in the control group), though the reasons for this were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05640648 · results posted 30 March 2025

  According to the results reported on ClinicalTrials.gov, this trial looked at two different approaches to "contact investigation" for tuberculosis (TB) — a process where health workers track down people who may have been exposed to someone with TB and arrange for them to be tested. The standard approach was compared with a "user-centred" approach, which was designed with input from the people using it. The trial ran across 12 health facilities and used a crossover design, meaning each facility took turns using both approaches across different time periods. Participants included both "index" individuals (people newly diagnosed with TB) and their close contacts. In total, across all periods and sites, several thousand participants took part — including hundreds of index participants and their close contacts in each period — though the reported data does not provide a single combined total figure. The reported data shows results were measured across multiple eight-week periods at each site. The numbers of people enrolled varied considerably between periods and sites — for example, in a single period at one site, as many as 495 people participated, while at others the figure was as low as 73. The data shows that in every period, all participants who started also completed that period (no dropouts were recorded). However, the specific outcome measure results — such as the proportion of close contacts who were successfully tested for TB under each approach — were not included in the portion of the structured data provided, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02906007 · results posted 21 March 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 54 children with HIV across three age groups: 18 children aged 6 to under 18 years (Cohort 1), 18 children aged 2 to under 6 years (Cohort 2), and 18 infants and toddlers aged under 2 years (Cohort 3). The trial was measuring a range of safety-related events — including serious unwanted health events, deaths, heart rhythm problems, and whether any child had to stop the study drug because of a drug-related event — over the course of the study. The reported data shows that when it came to serious unwanted health events (graded "severe" or worse on a 1–5 scale), 38.9% of children in the oldest group, 11.1% in the middle group, and 83.3% in the youngest group experienced at least one such event during the study. However, when a review team assessed which of those events were considered at least possibly linked to the study drug, the reported figures were much lower: 5.6% in the oldest group and 0% in each of the two younger groups. The reported data also shows that 0% of participants across all three groups stopped the study drug due to a drug-related event. One death was reported in the oldest group (5.6%), with 0% deaths reported in the other two groups; the data does not specify whether this death was linked to the study drug. Regarding heart rhythm concerns, 5.6% of the oldest group had a particular heart measurement (a reading of the heart's electrical timing called QTcF) reach or exceed 500 milliseconds — a level considered notable — while 0% in the two younger groups reached that threshold. No participants in any group experienced unstable heart rhythm problems requiring hospitalisation and treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03544476 · results posted 10 March 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03544476) looked at whether a mobile phone app designed to support tuberculosis (TB) treatment could help people stay on track with their medication. A total of 42 people took part — 21 who used the mobile phone TB treatment support app, and 21 who received usual care. Everyone who started the trial also completed it, with no drop-outs recorded in either group. The reported data shows that, for the main outcome — the number of people who achieved "treatment success" (meaning they either completed their course of TB treatment or were confirmed cured based on test results) — 20 out of 21 people in the app group met this measure, compared with 17 out of 21 in the usual care group. For a secondary measure, the app group was also tracked on how consistently they used the app to report taking their medication over the 180-day treatment period; on average, participants in that group reported through the app on approximately 147 out of 180 days. No equivalent figure was reported for the usual care group, as they did not use the app. The reported data also shows that, when it came to checking whether participants had access to a phone and internet (to assess how practical the app might be to roll out), 10 out of 21 in the app group and 6 out of 21 in the usual care group were recorded as having that access. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05282173 · results posted 6 March 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 82 community health workers (CHWs) across three groups, with 73 completing the study. The trial was testing a training programme called "Siyakhana," designed for community health workers. It looked at whether the training was practical to deliver and acceptable to those who took part, and also measured whether the training was associated with any changes in how much stigma (negative attitudes or desire to avoid) the health workers held towards people with substance use issues or depression. The reported data shows that attendance at all three days of the Siyakhana training was high: 26 out of 29, 25 out of 25, and 27 out of 28 participants completed the full training across the three groups — all above the 75% target the researchers set as a marker of feasibility. On a satisfaction and acceptability scale ranging from 0 to 3, the three groups scored 2.92, 2.84, and 2.80 respectively, which sits toward the higher end of that scale. For how well the health workers were able to apply their training skills (fidelity), the reported figures were 86.7%, 85.7%, and 82.7% of skills demonstrated competently across the three groups. Regarding stigma, the reported data shows a change score of −0.88 on a 6–24 scale for attitudes toward substance use (where a lower score means less social distance, or less stigma), and a change score of +0.15 for attitudes toward depression — meaning the reported change in depression-related stigma was very small. A secondary measure of substance use stigma reported a change of −1.22. These are changes from before to after the training, though it is important to note that this was not a comparison against a separate control group for the stigma outcome specifically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03044158 · results posted 18 February 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 10,644 people in total — 5,098 in the control group and 5,546 in the intervention group. Every person who started the trial was recorded as completing it, with no drop-outs reported in either group. The trial was measuring outcomes related to tuberculosis (TB) diagnosis and treatment, comparing two groups to see whether differences could be observed in how quickly and how often people were diagnosed and started on treatment for TB. The reported data shows that for the main (primary) outcome — the number of people treated for laboratory-confirmed TB within 14 days of visiting a health centre — 220 people in the control group and 342 people in the intervention group met this measure. For the secondary outcomes: the number of people diagnosed with laboratory-confirmed TB was 299 in the control group and 389 in the intervention group; the number treated for TB overall (not limited to laboratory-confirmed cases) was 339 in the control group and 485 in the intervention group; and the number of people who died within six months was 123 in the control group and 116 in the intervention group. For the time-based measures — how many days it took to receive a diagnosis or start treatment — the reported values were 0 or 1 day across both groups, though no further detail was provided to explain these figures, so their meaning is unclear from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04520113 · results posted 10 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04520113) was conducted across two sites in South Africa — Limpopo and Soshanguve — and involved a total of 10,579 participants across four groups. The study was looking at different ways of tracing the close contacts of people newly diagnosed with tuberculosis (TB). The four approaches tested were: standard contact tracing in Limpopo (4,368 participants), a "holiday tracing" approach where visits were timed around public holidays (1,952 participants), an "evening and weekend tracing" approach (1,320 participants), and standard contact tracing in Soshanguve (2,939 participants). Within each group, participants were either TB index cases — the person originally diagnosed with TB — or contact persons, meaning people who had been in close contact with them. The reported data shows that the main thing being measured was the average number of additional TB cases found and started on treatment for every one index case in each group. According to the results reported on ClinicalTrials.gov, the standard tracing group in Limpopo had an average of 1.7 additional TB cases identified and started on treatment per index case; the holiday tracing group reported an average of 1.2; the evening and weekend tracing group reported an average of 2.3; and the standard tracing group in Soshanguve reported an average of 2.4. These are averages — meaning the actual number varied from household to household within each group. The trial also listed several secondary outcomes, including comparisons of TB rates between people who travel frequently versus those who don't, how acceptable each tracing approach was to participants, and how well each approach was carried out in practice. However, the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these secondary outcomes, so those figures are not available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03492216 · results posted 13 January 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 680 people across four groups. All participants were people living with HIV who were also taking isoniazid (a medicine used to prevent tuberculosis). The trial was testing whether offering financial rewards — called incentives — could encourage people to drink alcohol at lower-risk levels and to take their isoniazid medicine more consistently. Participants were randomly placed into one of four groups: a control group (no incentives), a group offered incentives based on urine alcohol tests, a group offered incentives based on a different type of urine alcohol test, or a group offered incentives based on both types of tests. The study ran for up to 12 months, with check-ins at 3 and 6 months. The reported data shows that for the main drinking-related goal — which required a person to report low-risk drinking AND have a low blood marker of alcohol use at both the 3-month and 6-month visits — 57 out of 323 participants in the group offered alcohol-related incentives met this combined measure, compared with 31 out of 313 participants in the group not offered those incentives. For the medicine-taking goal, 244 out of 335 participants offered isoniazid-related incentives took more than 90% of their prescribed doses, compared with 234 out of 321 participants in the group not offered those incentives. Regarding a secondary measure of liver-related side effects serious enough to stop isoniazid treatment, the reported numbers across the four groups were 13, 10, 15, and 9 participants respectively. For HIV viral suppression at 12 months, the reported data shows 144, 147, 146, and 146 participants across the four groups had their virus at very low levels, while 4, 8, 3, and 2 participants respectively did not. The number of participants diagnosed with active tuberculosis during the study was 0, 1, 2, and 1 across the four groups. Hair sample measurements for isoniazid concentration were only reported for two of the four groups, and figures for the other two groups were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02619994 · results posted 3 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT02619994) enrolled 214 people in total — 106 in the control arm and 108 in the experimental arm. The trial was comparing two different treatment approaches, measuring things like how many participants achieved "treatment success," how quickly their sputum (mucus coughed up from the lungs) cleared of bacteria, and whether bacteria came back after treatment ended. Not everyone finished the trial: 89 people in the control arm and 79 in the experimental arm completed it. The reported data shows that for the main outcome — treatment success rate — 60 participants in the control arm and 54 in the experimental arm met that measure. For the secondary outcomes, the reported median time for sputum cultures (lab tests on mucus samples) to stop showing bacteria was 24 days in the control arm and 27 days in the experimental arm. When looking at culture conversion (the point at which the mucus samples no longer tested positive for bacteria) at the two-month mark, 42 participants in the control arm and 35 in the experimental arm had reached that point. At the end of the full treatment period, 64 people in the control arm and 61 in the experimental arm were recorded as treatment successes. The reported data also shows that reverting to a positive sputum culture after treatment ended occurred in 0 participants in the control arm and 1 participant in the experimental arm. In a subgroup of participants whose bacteria showed resistance to a medicine called pyrazinamide, 13 in the control arm and 19 in the experimental arm were recorded as treatment successes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04874948 · results posted 5 December 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 4 healthy adult male volunteers, and all 4 completed the study. The trial was investigating a drug called BTZ-043, which is being researched in relation to tuberculosis. Participants received a single oral dose of 500 mg of BTZ-043 that contained a small amount of a radioactive "tracer" version of the drug. This tracer allowed researchers to track where the drug and its breakdown products (called metabolites) travelled in the body, how quickly they were absorbed into the bloodstream, and how they were eventually removed from the body through urine, faeces, or vomit. The reported data shows that, when measuring how much of the drug-related radioactivity left the body through excretion, the figures recorded were 331 mg equivalents and 162 mg equivalents (units representing amounts comparable to 1 mg of the original drug). For how much drug-related radioactivity reached the bloodstream, the reported peak levels were 8,730 ng equivalents per millilitre in whole blood and 4,970 ng equivalents per millilitre in plasma (the liquid part of blood). The reported figures for total drug-related radioactivity exposure over time were 125,000 and 76,700 (measured in hours multiplied by ng equivalents per millilitre, a way of capturing both the amount and the duration of the drug's presence). The time it took for half of the radioactivity to clear — known as the "half-life" — was reported as 158 hours in whole blood and 186 hours in plasma. Separately, the reported peak blood levels for BTZ-043 itself and several of its breakdown products were 1,600, 163, 5,180, 1,190, and 30.6 nanograms per millilitre respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04550832 · results posted 28 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04550832) enrolled 76 people across five groups to study different doses of a drug referred to as DZD (dazanamide) for tuberculosis. The groups were: a placebo group receiving no active drug (15 people), and four groups receiving different doses — 400 mg once daily (15 people), 800 mg once daily (15 people), 1,200 mg once daily (16 people), and 800 mg twice daily (15 people). The trial was primarily measuring how often participants experienced side effects, and also looking at how the drug moved through the body and whether it was associated with changes in the amount of tuberculosis bacteria detectable in sputum (mucus coughed up from the lungs) over time. The reported data shows that, for the primary safety outcome, the number of participants who experienced at least one adverse event (an unwanted health event during the study) was: 8 in the placebo group, 7 in the 400 mg group, 7 in the 800 mg once-daily group, 6 in the 1,200 mg group, and 9 in the 800 mg twice-daily group. For the drug levels in the blood, the reported data shows that higher doses were generally associated with higher overall drug exposure (measured in mg/L\*h): 10.1 for the 400 mg group, 28.6 for the 800 mg once-daily group, 47.0 for the 1,200 mg group, and 68.5 for the 800 mg twice-daily group, with no figure applicable for the placebo group. For the secondary outcome measuring bacteria levels in sputum over time, the reported change figures varied across groups and time points — for example, the average number of days before bacteria were detectable in a lab culture started at 5.6 days (placebo) and 6.5 days (400 mg group) at the beginning of treatment, rising to 13.3 and 16.9 days respectively at a later time point, with other dose groups showing similar patterns; not all time-point values were fully reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04179500 · results posted 19 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 26 male participants who received a treatment regimen referred to as BPaMZ — a combination of tuberculosis medicines. The trial was measuring how the treatment affected sperm count over time, as well as tracking certain hormone levels in the blood. Of the 26 who started the treatment phase, 22 completed it, and 18 completed the full follow-up period. The reported data shows that the main thing being measured was the change in total sperm count (the number of sperm cells in a single ejaculate, measured in millions) from the start of the trial to 26 weeks into treatment. The reported change at that point was 20 million sperm cells per ejaculate. At 12 weeks into treatment, the reported change from the starting point was 4.2 million, and at 44 weeks — which was about 18 months after treatment had finished — it was reported as 4.4 million. The trial also measured three hormones: LH, FSH, and testosterone. For LH, the reported levels went from 5.8 at the start to 4.6 at 26 weeks, 3.6 at 44 weeks, and 4.0 at 78 weeks. FSH went from 6.6 at the start to 6.2, then 5.2, then 4.6 at those same time points. Testosterone (measured in ng/dL, a standard unit of concentration) was reported as 547 at the start, rising to 600 at 26 weeks, 646 at 44 weeks, and 615.5 at 78 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05122624 · results posted 23 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT05122624) involved 3,332 people across two groups — 1,826 in the "Score Intervention Arm" (where a tool called PredicTB was used to guide decisions about starting tuberculosis treatment on the same day) and 1,506 in the "Control Arm" (where standard care was provided). All participants who started the trial completed it. The trial was primarily measuring whether using the PredicTB scoring tool changed how quickly people with confirmed tuberculosis (TB) began treatment, specifically whether they started within 7 days. The reported data shows that in the intervention group, the proportion of people starting TB treatment within 7 days went up by 1 percentage point from before to after the tool was introduced, while in the control group that same figure went down by 13 percentage points over the same period. When comparing the two groups directly, the reported difference was 14 percentage points in favour of the intervention arm versus no change in the control arm. The reported data also shows that 46% of patients in the intervention arm whose PredicTB score indicated same-day treatment actually went on to start treatment on that same day. For the secondary outcomes, both groups saw a 1 percentage point decrease in TB-related deaths from the earlier period to the later period, and both groups saw a 1 percentage point increase in people who were lost to follow-up (meaning they stopped engaging with their care). The cost-effectiveness outcome was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04188041 · results posted 19 July 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a programme designed to improve how healthcare providers identify and manage latent tuberculosis infection (LTBI — where someone carries the TB bacteria but is not yet ill). The study had three separate parts: one involving 25 people who took part in interviews about the topic; one involving 8 healthcare providers who joined an online learning programme called ECHO (a type of regular group learning session); and one involving a review of 51 patient medical records. The focus of the ECHO part — which is where most of the outcome measurements came from — was on whether the programme was practical to run and whether it had any impact on participants' knowledge and reported practice. The reported data shows that across seven ECHO sessions, attendance among consenting participants ranged from 6 to 10 people per session, and 9 participants attended at least one of the final two sessions. When asked how confident they felt assessing a patient's TB risk (on a scale of 1 to 5), participants reported an average score of 3.09 before the programme and 4.25 afterwards. Participants' self-reported estimates of how many of their patients they screened for TB infection averaged 45.67% before the programme and 25.86% afterwards. Their estimates of how many patients they started on TB treatment averaged 50% before and 11% afterwards. For the outcome measuring actual TB testing rates in patient records, no figures were reported in the submitted data. The reported data shows some notable changes in participants' self-reported numbers between the start and end of the programme; however, these figures reflect what a small group of participants said about their own practice, and this summary is not able to explain why numbers went up or down. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03421743 · results posted 3 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03421743) enrolled 32 people in total across two groups. Fourteen participants received inhaled molgramostim (a type of inhaled medication) combined with standard antimycobacterial antibiotics, while 18 received inhaled molgramostim on its own. The trial was primarily measuring whether a bacterial infection in the lungs — caused by non-tuberculous mycobacteria (NTM), a type of germ found in the environment — could be cleared from participants' sputum (mucus coughed up from the lungs). Eleven people in the combination group and 16 in the molgramostim-only group completed the study. The reported data shows that for the main outcome — clearing the NTM bacteria from sputum cultures (lab tests that check for bacterial growth) — 2 out of 14 participants in the combination group and 3 out of 18 in the molgramostim-only group met that measure. For a related secondary measure looking at sputum smear tests (a quicker microscope-based check for bacteria), 5 participants in the combination group and 6 in the molgramostim-only group showed conversion to negative. When the researchers looked at whether these clearances lasted to a 12-week follow-up, only 1 participant in each group maintained a negative culture result, while durable negative smear results were reported for 5 and 6 participants respectively. Changes in symptom scores and quality-of-life questionnaire scores were also measured across both groups, with the reported numbers varying across different symptom categories; some scores shifted in one direction and some in the other, and the data does not indicate any clear or consistent pattern in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04176250 · results posted 11 April 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04176250) enrolled 93 people across six groups to study a new experimental drug called TBA-7371 for tuberculosis (TB). Four groups received different doses and schedules of TBA-7371, one group received it three times a day at 100 mg, and one comparison group received a standard four-drug TB treatment (known as HRZE). The trial ran for 14 days and was primarily measuring how quickly the amount of TB bacteria in participants' sputum (phlegm) changed over that period, as well as tracking serious unwanted medical events. The reported data shows that for the main bacteria-count measure — the average daily change in TB bacterial levels in sputum over 14 days — all groups showed a negative number, meaning bacterial levels were falling on average across all groups. The comparison HRZE group showed the largest recorded daily fall (−0.203 units per day), while the TBA-7371 groups ranged from −0.039 (100 mg once daily) to −0.130 (100 mg three times daily). For severe unwanted medical events (Grade 3 or above), the reported data shows zero participants in the 100 mg once-daily and 400 mg once-daily TBA-7371 groups, one participant each in the 100 mg twice-daily and 200 mg once-daily groups, and two participants in the 100 mg three-times-daily group; the HRZE comparison group reported three such events. For any unwanted medical event of any severity, the numbers ranged from 11 to 15 participants across all groups, with all but one group (400 mg once daily, where all 15 reported at least one event) reporting between 11 and 14 participants affected. The secondary measures — including additional time-window bacteria counts, a separate bacterial growth test (MGIT), and a different marker in sputum called LAM — were also reported for all groups, with the HRZE comparison group generally showing the largest recorded changes across these measures as well. The reported data for the MGIT secondary measure was not broken down into all sub-periods for every group in a complete way, and some sub-period figures were not reported for the days 0–2 MGIT window. Where data was reported, all TBA-7371 dose groups showed positive MGIT values (indicating the time it took for bacteria to grow in a lab test was getting longer), with values ranging from 2.334 to 5.547 hours per day over the full 14 days, compared to 13.877 hours per day for the HRZE group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05124665 · results posted 14 February 2024

  According to the results reported on ClinicalTrials.gov, this trial involved 612 participants in total across two groups in Uganda. The Social Support group had 364 participants (79 "index patients" — people already known to have HIV or TB — and 285 of their household contacts). The Standard of Care group had 248 participants (61 index patients and 187 household contacts). The trial was measuring whether a social support-based approach could increase the number of household contacts who agreed to be tested for HIV, and whether it was associated with changes in how much stigma people felt around HIV and TB. The reported data shows that, for the primary outcome — how many household contacts agreed to take an HIV test — 279 out of 285 contacts in the Social Support group and 172 out of 187 contacts in the Standard of Care group were recorded as accepting a test. For the secondary outcomes, the trial used a stigma scale running from 0 to 100, where higher numbers mean greater perceived stigma. The reported data shows that perceived HIV stigma scores changed by +2.57 points in the Social Support group and –0.21 points in the Standard of Care group. Perceived TB stigma scores changed by +0.47 points in the Social Support group and –2.52 points in the Standard of Care group. The trial also looked at whether stigma levels appeared to influence test uptake; the reported figures for that analysis were +2.59 (HIV stigma, Social Support) versus –0.17 (Standard of Care), and –0.46 (TB stigma, Social Support) versus –2.34 (Standard of Care). Finally, among household members that the index patient specifically nominated as likely to accept a test, 58 in the Social Support group and 33 in the Standard of Care group were reported as having accepted one. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05065905 · results posted 25 January 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT05065905) involved 78 people in total, divided into three groups: 30 people in the "Interferon" group, 28 in the "Interferon Daily" group, and 20 in a "Control" group. All 78 participants completed the study. The trial was measuring things like sputum culture results (a test that checks for bacteria or other germs in mucus coughed up from the lungs), as well as various blood measurements including haemoglobin levels, white blood cell counts, and certain immune cell levels. The reported data shows that for the main outcome — the number of participants whose sputum culture came back negative (meaning no detectable germs were found in the sample) — 15 out of 30 people in the Interferon group, 20 out of 28 in the Interferon Daily group, and 14 out of 20 in the Control group had a negative result. For the secondary outcomes — including haemoglobin levels, white blood cell counts, and immune cell measurements (referred to as CD3, CD4, and CD8 cells) — the data was not reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03678688 · results posted 18 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03678688) enrolled 122 adults with tuberculosis (TB) across two stages. Stage 1 tested four different doses of an experimental drug called OPC-167832 (3 mg, 10 mg, 30 mg, and 90 mg) against a standard TB treatment combination known as RHEZ. Stage 2 tested the 30 mg dose of OPC-167832 combined with one or both of two other TB drugs — delamanid and bedaquiline (BDQ) — again alongside a RHEZ comparison group. The trial was measuring two main things: how quickly the TB bacteria in participants' sputum (phlegm) declined over the first 14 days of treatment, and how the drug moved through the body at different doses and combinations (known as pharmacokinetics). The reported data shows that in Stage 1, the amount of TB bacteria in sputum dropped across all groups over 14 days. The reported average daily decline (expressed on a scientific log scale) was −1.69 for the 3 mg dose, −1.93 for 10 mg, −2.12 for 30 mg, −2.08 for 90 mg, and −2.79 for the RHEZ comparison group. For the drug-level measurements, the reported peak concentration of OPC-167832 in the blood rose with increasing dose in Stage 1 — from 20.7 ng/mL at 10 mg up to 391 ng/mL at 90 mg. In Stage 2, when the 30 mg dose was combined with delamanid, BDQ, or both, the reported peak blood levels were 157, 154, and 140 ng/mL respectively, which were similar to each other and to the 30 mg dose given alone (128 ng/mL). The time taken to reach peak blood levels was broadly consistent across all groups, sitting between roughly 2.8 and 4.2 hours. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03934931 · results posted 7 November 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03934931) involved 1,656 people living with HIV across three groups of 552 each. The trial was testing a tuberculosis (TB) prevention treatment called "3HP" — a short course of two medicines (rifapentine and isoniazid) taken once a week for 12 weeks. The three groups differed in *how* the treatment was given: one group took it under direct supervision (Directly Observed Therapy, or DOT), one group took it on their own (Self-Administered Therapy, or SAT), and the third group got to choose which approach they preferred. The main thing researchers were measuring was how many people both agreed to start the treatment *and* finished at least 11 of the 12 doses within 16 weeks. The reported data shows that across all three groups, the proportion of people who both accepted and completed the course was very similar and high. In the DOT group, the reported figure was 0.946 (meaning about 94.6 in every 100 participants); in the SAT group it was 0.922 (about 92.2 in 100); and in the patient-choice group it was 0.944 (about 94.4 in 100). The reported data also shows that nearly all participants in every group agreed to start treatment in the first place — the figures were 0.998, 1.00, and 0.995 respectively. Among those who did start, the proportion who finished the course was similarly high across all three groups (roughly 94–95 in 100 for DOT and patient-choice, and about 92 in 100 for SAT). The proportion of participants who stopped treatment early because of side effects or intolerance was reported as very small in all three groups — ranging from about 0.5 in 100 (DOT group) to about 1.3 in 100 (SAT group). The reported data shows that the two outcomes measuring TB incidence at 16 months and 28 months were listed in the trial record but no results figures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03557281 · results posted 26 October 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 76 people in total across five groups. Participants were adults with tuberculosis (TB) who were randomly assigned to receive one of four different doses of an investigational medicine called GSK3036656 (1 mg, 5 mg, 15 mg, or 30 mg daily), or a standard TB treatment called Rifafour e-275, which served as a comparison group. The trial ran for 14 days and was primarily measuring what researchers call "early bactericidal activity" — in plain terms, how much the number of live TB bacteria in participants' sputum (the mucus coughed up from the lungs) changed over the course of treatment. The reported data shows that the primary outcome — the change in TB bacterial count in sputum from the start of the study to Day 14 — was measured as a change in a laboratory unit called log10 CFU/mL (essentially a mathematical scale for counting bacteria). The Rifafour e-275 comparison group showed a change of −0.199 in this unit, meaning the bacterial count in sputum went down by that amount on this scale. The four GSK3036656 dose groups showed changes of −0.017 (1 mg), −0.092 (5 mg), −0.092 (15 mg), and −0.138 (30 mg) respectively over the same 14-day period. The reported data also shows secondary measurements at Day 2 and between Day 2 and Day 14, as well as a separate measure of how long it took bacteria to grow in a laboratory culture tube — with all groups showing only small changes on those measures across the study period. The numbers for how long it took bacteria to grow in the lab (measured in log10 hours) ranged from 0.000 to 0.025 across groups from the start to Day 14. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03510468 · results posted 25 October 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 28 healthy adult volunteers in a single group. Of those, 18 completed the study and 10 did not finish. The trial was a pharmacokinetic study — meaning it was designed to measure how a drug moves through the body — specifically looking at two related substances: tenofovir alafenamide (TAF, the medicine as taken) and tenofovir (TFV, the active form the body converts it into). Measurements were taken on three separate days (days 14, 22, and 31) to track how drug levels in the blood changed over time under different conditions. The reported data shows the following blood-level measurements across the three testing days. For TAF, the total amount absorbed into the blood over 24 hours (a measure called AUC, or "area under the curve") was reported as 295.5, 472.1, and 248.1 hr·ng/mL on the three days respectively. For TFV, the same measure was 262.2, 265.3, and 230.8 hr·ng/mL. The peak blood concentration (the highest level detected) for TAF on those days was 208.9, 335.2, and 179.1 ng/mL, while for TFV it was 16.5, 16.5, and 13.8 ng/mL. The time it took to reach that peak was approximately half an hour for TAF across all three days, and consistently 4 hours for TFV across all three days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03302299 · results posted 19 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03302299) enrolled 302 people, all of whom received a combination of isoniazid (INH — a medication used to prevent tuberculosis) and Vitamin B6. The trial was a single-group study, meaning everyone received the same treatment — there was no comparison group. The main thing the trial was set up to measure was how often participants experienced a serious liver reaction (called Grade 3/4 hepatotoxicity, meaning a significant rise in markers of liver stress) while taking the medication. It also tracked whether people stayed on the medication, and how consistently they took it over a six-month treatment course. The reported data shows that 8.3% of participants experienced a serious liver reaction at some point during the treatment period. Regarding staying on treatment, 32 out of 302 participants stopped taking isoniazid before completing the full course, due to side effects or abnormal liver test results. When it came to how consistently people took their medication — measured using an electronic pill cap that recorded each time the bottle was opened — 31.3% of participants showed less-than-recommended adherence at the three-month mark, and this figure rose to 43.9% at six months. When participants were asked to rate their own adherence over the past 30 days, the reported data shows the majority rated themselves as taking the medication "excellently" or "very well" at both time points, though the exact breakdown across rating categories was also recorded. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02409290 · results posted 28 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (known as STREAM Stage 2) enrolled 588 people across four different treatment groups, all receiving different drug regimens for tuberculosis. The groups were labelled Regimen A (Long Regimen, 32 participants), Regimen B (Control Regimen, 202 participants), Regimen C (Oral Regimen, 211 participants), and Regimen D (6-month Regimen, 143 participants). The trial was measuring how many participants in each group had a "favourable outcome" — meaning their condition had responded as hoped — at 76 weeks into the study, and also tracked results over a longer follow-up period of 132 weeks. Notably, none of the participants in Regimen A completed the study, so no results for that group were reported for most of the main outcome measures. The reported data shows that at the 76-week mark (the main measurement point), favourable outcomes were recorded for 133 out of 202 participants in Regimen B, 162 out of 211 in Regimen C, and 122 out of 143 in Regimen D. No figure was reported for Regimen A. At the longer 132-week follow-up, the reported data shows favourable outcomes for 17 out of 32 in Regimen A, 126 out of 202 in Regimen B, 152 out of 211 in Regimen C, and 115 out of 143 in Regimen D. The trial also tracked how many participants developed resistance to any of the drugs used: the reported data shows this occurred in 5 participants in Regimen B, 5 in Regimen C, and 3 in Regimen D, with no figure reported for Regimen A. Regarding treatment failure or the condition coming back, the reported data shows this occurred in 17 participants in Regimen B, 4 in Regimen C, and none in Regimen D (with Regimen A again not reported for this measure). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03891901 · results posted 28 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03891901) enrolled 24 people across several groups. The main groups that received treatment were: 16 people in Cohort 1a (imatinib 50 mg combined with two tuberculosis medicines, rifabutin and isoniazid) and 6 people in Cohort 1b (imatinib 100 mg with the same two medicines), plus 2 people who received imatinib 100 mg on its own. Several planned higher-dose groups (Cohorts 1c, 1d, 2a, 2b, and imatinib 200 mg and 400 mg alone) had no participants enrolled. The trial was measuring a type of immune cell in the blood called myelomonocytic cells — the researchers tracked whether these cell counts changed over time — as well as recording any serious or severe unwanted health events (called adverse events) that occurred during the study. The reported data shows that myelomonocytic cell counts (measured in cells per tiny unit of blood called a microlitre) were broadly similar across the three groups at multiple time points, ranging roughly from about 2,500 to 4,300 cells per microlitre. For serious unwanted health events, the reported count was zero across all three groups. For severe unwanted health events (graded 3 or 4 on a standard severity scale), the reported numbers were 4 events in Cohort 1a, 6 events in Cohort 1b, and 0 in the imatinib-only group. White blood cell counts across all groups stayed largely within or near the broadly normal reference range throughout the study. Regarding how the drug moved through the body, the reported peak blood concentration of imatinib ranged from 0.41 to 0.71 micrograms per millilitre depending on dose and combination, and the time for the drug level to fall by half ranged from approximately 7.8 to 15 hours. Some measurements for the higher-dose combination phases were not reported in the data, likely because those groups did not enrol any participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03851588 · results posted 18 September 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03851588) enrolled 108 people in total — 53 in the supplementary dose group and 55 in the placebo group. Most participants completed the study (51 and 52 respectively). The trial was measuring whether adding a supplementary dose of an HIV medicine called dolutegravir made a difference to the number of people whose HIV viral load (the amount of HIV detected in the blood) dropped below 50 copies per millilitre — a level described as "virologically suppressed." These measurements were taken at 12, 24, and 48 weeks. The reported data shows that at 24 weeks, 43 out of 53 participants in the supplementary dose group and 44 out of 55 in the placebo group had a viral load below 50 copies per millilitre. At 12 weeks, those numbers were 42 (supplementary dose) and 46 (placebo). At 48 weeks, 34 participants in each group had a viral load below 50 copies per millilitre. These 24-week and 48-week counts were consistent whether analysed by two different counting methods (one that included everyone who received at least one dose, and one that only included people who followed the study plan fully). The trial also tracked a measure of immune health called CD4 cell count; the reported data shows an average increase of 111 cells per microlitre in the supplementary dose group and 101 cells per microlitre in the placebo group from the start of the study to week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05203068 · results posted 25 August 2023

  According to the results reported on ClinicalTrials.gov, this trial tested a recombinant tuberculosis allergen called CFP10-ESAT6 (also referred to as RTA), which is a skin test used to detect whether someone has been exposed to tuberculosis. A total of 150 volunteers took part, and all 150 completed both stages of the study — a 72-hour check of the skin test result and a 28-day follow-up for any reactions. The reported data shows that when the skin test results were read at 72 hours, 145 out of 150 participants recorded a negative result (meaning no visible skin reaction suggesting tuberculosis exposure), while 5 out of 150 recorded a positive result. For the secondary measurements, the reported data shows that zero participants experienced a local reaction at the injection site (such as redness or swelling) within the first 72 hours. Over the full 28-day follow-up period, the reported data shows that 1 participant experienced a general reaction (such as infection, fever, headache, or weakness), zero participants experienced a local injection site reaction, and 149 participants experienced neither type of reaction. It is worth noting that the data as submitted contains two separate measurements for the primary outcome without clearly labelling which number corresponds to which result, so the figures above reflect the most straightforward reading of the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04463680 · results posted 9 May 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants, all of whom received rifampin 600 mg. The trial was measuring levels of a hormone called etonogestrel in the blood — etonogestrel is the active hormone released by certain contraceptive implants. The goal was to see how those blood levels compared before and after two weeks of rifampin (an antibiotic) was taken. Of the 24 people who started, 15 completed the study and 9 did not finish. The reported data shows that average etonogestrel levels in the blood were measured at two points: before rifampin was taken, the reported figure was 164.0 pg/mL (picograms per millilitre, a standard unit for measuring tiny amounts of a substance in blood), and after two weeks of taking rifampin, the reported figure was 47.8 pg/mL. No secondary outcome measures were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01936831 · results posted 17 February 2023

  According to the results reported on ClinicalTrials.gov, this trial involved people with tuberculosis (TB) who were first tested to identify which genetic mutation their TB bacteria carried — either an *inhA* mutation (110 people), a *katG* mutation (87 people), or neither mutation (85 people). Based on those results, participants were then assigned to receive different doses of isoniazid, a TB antibiotic, and monitored for seven days. The trial was measuring how much the bacteria in participants' sputum (phlegm) changed over those seven days, how the drug moved through the body at different doses, and how many participants experienced notable side effects considered related to the drug. The reported data shows that, when looking at the daily change in bacteria levels measured by counting bacterial colonies, the numbers ranged from a decrease of 0.06 log units per day (in the Group 1, 5 mg dose cohort) to a decrease of 0.21 log units per day (in the Group 1, 15 mg dose cohort) — where a larger negative number means a greater reduction in bacteria. A second bacteria measure used a different detection method (time for bacteria to grow in a lab test, reported in hours per day); higher numbers here also indicate greater reductions, and the reported figures ranged from 2.0 to 10 hours per day across the different groups and doses. Regarding how the drug was absorbed into the body (measured as total drug exposure over 24 hours), the reported values ranged from 10.47 to 70.54 micrograms per hour per millilitre depending on the group and dose. For side effects rated as moderate or higher and considered drug-related, the reported data shows that most cohorts had zero or one such participant, with the Group 1, 10 mg cohort reporting four participants with such events. The reported data also shows the maximum drug concentration in the blood ranged from 4.55 to 22.15 micrograms per millilitre across the different groups and doses, while the minimum concentration figures were reported as the same value (0.053 micrograms per millilitre) across all groups, which may reflect a lower detection limit rather than a true measured value — the data as submitted does not clarify this further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02808507 · results posted 2 December 2022

  According to the results reported on ClinicalTrials.gov, this trial looked at different ways of finding and starting treatment for people with tuberculosis (TB) in what appears to be a community health setting. A total of 4,852 people took part across three groups: 1,929 in a facility-based screening group (where people came to a clinic to be screened), 1,413 in a household-based contact tracing group (where health workers visited the homes of people known to have TB to check family members), and 1,510 in an incentive-based contact tracing group (a similar home-visiting approach but with some form of incentive offered). All participants who started the study were recorded as having completed it. The reported data shows that for the main comparison between facility-based and contact-based screening, 1,929 people in the facility group and 1,726 people across both contact tracing groups were counted for the treatment initiation measure. When comparing the two contact tracing approaches against each other, 1,413 people were counted in the household-based group and 1,510 in the incentive-based group. For a secondary measure — the number of TB cases found among the contacts of known TB patients — both groups recorded exactly 17 cases each. On the cost side, the reported data shows the total cost of running the household-based contact tracing program was approximately US$48,760, compared with US$58,070 for the incentive-based program. The estimated cost to screen each individual contact was about US$26.44 in the household-based group and US$29.93 in the incentive-based group. The estimated cost for each new TB case identified among contacts was reported as approximately US$2,927 in the household-based group and US$2,416 in the incentive-based group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02554318 · results posted 21 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02554318) involved 147 people in total — 75 in the intervention group and 72 in the control group. Of those, 65 and 64 respectively completed the study. The trial was measuring changes over two months in body weight, grip strength, how far participants could walk in six minutes, and body mass index (BMI — a number calculated from a person's height and weight). The reported data shows the following changes from the start of the study to the two-month mark. For body weight, the intervention group recorded an average increase of 2.80 kg, compared to 1.44 kg in the control group. For hand-grip strength (measured using a hand-held squeezing device), the intervention group recorded an average increase of 3.90 kg of force, compared to 0.84 kg in the control group. In the six-minute walk test — where participants walked as far as they could in six minutes — the intervention group recorded an average increase in distance of 49.67 metres, compared to 25.75 metres in the control group. For BMI, the intervention group recorded an average increase of 1.13 kg/m², compared to 0.54 kg/m² in the control group. In all cases, a positive number indicates an increase from the starting point. Additional data on daily calorie and protein intake was also collected, though the reporting structure for those figures across time points was not entirely clear in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01864603 · results posted 2 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT01864603) involved very large numbers of people across two stages. In Stage 1, around 79,800 people were in the intervention group and about 70,600 were in the control group. In Stage 2, those numbers were approximately 91,500 and 92,600 respectively. The trial was measuring whether a community-wide program could reduce the rate of new HIV infections in men and women aged 15 and over, and also looked at a number of related outcomes including tuberculosis (TB), deaths, infant HIV infection, and whether people living with HIV had low levels of the virus in their blood. The reported data shows that for the main outcome measured during Stage 1, the cumulative (total over time) rate of new HIV infections over three years was 0.77 per 100 people in the intervention group, compared with 0.81 per 100 people in the control group. For the Stage 2 main outcome, the rate of new HIV infections per year was reported as 0.35 per 100 people per year in the intervention group and 0.92 per 100 people per year in the control group. For the secondary outcomes, the reported data shows the cumulative rate of TB or death among people already living with HIV was 3.7 per 100 in the intervention group versus 4.6 per 100 in the control group. Overall deaths among people living with HIV were reported at 3.0 per 100 compared with 3.9 per 100. For babies born to mothers living with HIV, 96.7 per 100 in the intervention group remained alive and HIV-free, compared with 93.6 per 100 in the control group. Finally, 79 out of every 100 adults living with HIV in the intervention group had very low levels of the virus in their blood (at or below 500 copies per millilitre), compared with 68 out of 100 in the control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT04553406 · results posted 28 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04553406) enrolled just 2 participants in total — one person received SPR720 (a drug being studied, at a dose of 500 mg) and one person received a placebo (an inactive substitute). The trial was measuring how the drug moves through the body over time — specifically, how quickly it is absorbed into the bloodstream, how high the levels in the blood get, and how much of the drug builds up over repeated doses. It also tracked any unwanted health events (called adverse events) that occurred during the study, and whether there were any notable changes in participants' physical examinations. The reported data shows that none of the main (primary) measurements about how the drug moves through the body were actually recorded — no numbers were submitted for any of those four primary outcomes. This likely reflects the very small number of participants and the fact that only one person in the SPR720 group completed the study, while the placebo participant did not complete it. For the secondary outcomes, the reported data shows that both participants — one in each group — experienced at least one adverse event (an unwanted health occurrence) during the study. However, no data was reported indicating that any of these events were severe, life-threatening, or fatal. The reported data also shows that neither participant had a clinically meaningful change noted during their physical examinations. It is worth noting that with only 2 participants enrolled and key outcome data not reported, the results are extremely limited in scope. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03948698 · results posted 20 December 2021

  According to the results reported on ClinicalTrials.gov, this trial — known as the CaP TB TIPPI Study — involved children aged 0 to 14 years attending health clinics, and was focused on tuberculosis (TB) screening and follow-up care for that age group. The study tracked how many children were screened for TB, how many were considered to possibly have TB, how many were sent for laboratory testing, and how many were started on or completed a course of TB preventive therapy (medicine given to reduce the chance of TB developing in someone who may have been exposed). The reported data shows that 4,749,072 children were screened for TB across the study. Of those, 60,250 were identified as having signs that suggested they might have TB (described as "presumptive TB"). Among that group, 49,022 were referred for laboratory-based testing, and 35,554 were tested using a specific diagnostic tool called GeneXpert (a machine that analyses a sample to look for signs of TB). The reported data also shows that 28,762 children were started on TB preventive therapy after being found eligible, and 22,590 of those children were reported to have completed that course of therapy. These figures represent counts across the full study period — no comparison group was included, so the numbers describe what was observed in this single group alone. No data appears to have been missing from the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00685360 · results posted 1 December 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT00685360) enrolled 481 people in total — 161 in the delamanid 100 mg twice-daily group, 160 in the delamanid 200 mg twice-daily group, and 160 in the placebo group. All participants also received a background regimen of other tuberculosis medicines (referred to as OBR). The trial was measuring, among other things, whether participants' sputum (mucus coughed up from the lungs) tested negative for tuberculosis bacteria over an 84-day period — a result called "sputum culture conversion." The trial also tracked how the drug moved through participants' bodies over time (its concentration in the blood). The reported data shows that, for the main clinical outcome — the percentage of participants whose sputum tested negative for tuberculosis bacteria and stayed negative — 45.4% of those in the delamanid 100 mg group achieved this, compared with 41.9% in the delamanid 200 mg group and 29.6% in the placebo group. Regarding how the drug behaved in the body, the reported data shows that the time it took for delamanid to reach its peak level in the blood was around 3 to 4 hours after the first dose. The peak blood concentration was higher in the 200 mg group (ranging from 187 to 599 nanograms per millilitre across measurement days) than in the 100 mg group (135 to 404 nanograms per millilitre). The drug also appeared to build up in the body over time, with levels on later measurement days being roughly 3 times higher than on the first day for both dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03819114 · results posted 30 November 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 122 participants across four groups. All participants were women living with HIV or undergoing tuberculosis (TB) treatment, and the trial was measuring how the body absorbs and processes levonorgestrel (LNG) — a hormone used in emergency contraception — when taken alongside certain other medications. The four groups were: 17 people taking a 1.5 mg dose of LNG while on an HIV treatment regimen containing efavirenz (EFV); 36 people taking a 3.0 mg dose of LNG also on that same HIV regimen; 35 people taking a 1.5 mg dose of LNG while on a different HIV regimen containing dolutegravir (DTG); and 34 people taking a 3.0 mg dose of LNG while on TB treatment containing rifampicin and isoniazid (RIF-INH). Nearly all participants completed the study, with only three people not finishing (one in Group B and two in Group C). The reported data shows the main thing being measured was how much LNG was present in the bloodstream over an eight-hour period after taking the dose — expressed as a number called the "area under the curve" (AUC), which is essentially a way of capturing the total drug exposure over time. The reported AUC figures were: 52.13 hours×ng/mL for the 1.5 mg group on EFV-based HIV treatment; 102.13 for the 3.0 mg group on EFV-based HIV treatment; 80.50 for the 1.5 mg group on DTG-based HIV treatment; and 124.39 for the 3.0 mg group on TB treatment. The reported data also shows the peak level of LNG in the blood (the highest concentration reached) was 15.10 ng/mL, 24.90 ng/mL, 18.65 ng/mL, and 28.01 ng/mL for each respective group. For the secondary outcome looking at adverse events (unwanted or unexpected health changes considered possibly or definitely linked to the LNG dose), the reported data shows 2 participants in the 1.5 mg group and 2 participants in the 3.0 mg group experienced such events. Additional measurements of how the body processed and cleared LNG were also reported for each group, but the clinical meaning of those figures is not something this summary can interpret. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01131351 · results posted 11 November 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people in total — 5 in a group receiving a lower dose of delamanid (250 mg twice daily) plus a standard background TB drug regimen, and 5 in a group receiving a higher dose (300 mg twice daily) plus the same background regimen. All 5 people in the lower-dose group completed the trial, while only 2 of the 5 in the higher-dose group completed it; the remaining 3 did not finish. The trial was measuring a range of physical checks — including vital signs, heart trace (ECG) readings, blood and urine tests, hearing, and vision — to track any notable changes from normal values during treatment. The reported data shows a number of findings across both groups. For vital signs (things like blood pressure, heart rate, and body temperature), 60% of participants in the lower-dose group and 0% in the higher-dose group showed at least one reading that met the study's definition of a notable change in one category, with varying percentages across other vital sign categories. For heart trace (ECG) readings, notable changes were recorded in both groups across several categories — for example, 80% of the higher-dose group showed a particular type of change in a heart rhythm measurement called QTcF (a way of adjusting a heart-timing reading), compared with 40% in the lower-dose group. For blood and urine tests, between 0% and 60% of participants in the lower-dose group and 20% in the higher-dose group showed values outside the normal range across different test categories. The reported data also shows that 100% of the lower-dose group and 80% of the higher-dose group had abnormal hearing test results, while 40% and 20% respectively had abnormal vision test results. All participants in both groups were taking additional TB medications throughout the trial. It is worth noting that because only 5 people were in each group, any percentage figure represents just one or two individuals, so these numbers should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02090374 · results posted 3 November 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 93 people across eight different groups. Each group received a different substance — including various doses of compounds called Poly ICLC, Poly I:C, and R848, as well as grass pollen, vitamin D, or tuberculin (a substance used in TB skin tests). All 93 participants who started the trial also completed it. The trial was measuring a protein called IFN-γ (interferon-gamma) in the fluid lining the nose, after participants received a nasal challenge (a substance delivered into the nose to prompt a response). IFN-γ is a protein the immune system can produce, and the trial tracked how much of it appeared in nasal fluid. The reported data shows the IFN-γ levels (measured in units of pg/hr/ml — a way of quantifying tiny amounts of protein over time) varied across groups. The Poly ICLC High Dose group (4 participants) had a reported level of 3.29, the Poly I:C Single Dose group (4 participants) recorded 9.42, the R848 High Dose group (9 participants) recorded 8.20, and the R848 Low Dose group (35 participants) recorded 5.10. For the remaining four groups — Poly ICLC Dose Escalation, Grass Pollen, Vitamin D Supplementation, and Tuberculin — the results were listed as "NA," meaning those figures were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT02573350 · results posted 1 November 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02573350) enrolled a total of 213 adults who were already receiving treatment for tuberculosis. Participants were split into two groups: 137 people received a lower dose of a drug called delamanid (100 mg twice daily) alongside their other tuberculosis medicines, and 76 people received a higher dose (200 mg twice daily) alongside the same background medicines. The trial was primarily measuring a range of physical checks — including vital signs like blood pressure, heart rate and weight; heart rhythm readings (ECGs); blood and urine laboratory tests; hearing; vision; and neurological or psychiatric assessments — to record what changes or abnormalities were observed during treatment. The reported data shows a variety of findings across these measurements. For vital signs, the numbers of participants recorded with notable changes were relatively small across both groups — for example, 34 participants in the lower-dose group and 25 in the higher-dose group showed flagged changes in body weight. For heart rhythm (ECG) readings, larger numbers were recorded with certain changes: for instance, 62 participants in the lower-dose group and 37 in the higher-dose group showed a particular type of change in a heart rhythm interval (called QTcB), and similar numbers were seen for a related measure (QTcF). For laboratory tests, the numbers with flagged abnormalities were generally in the single digits across most categories in both groups. Regarding hearing checks at the start of the study, 90 participants in the lower-dose group and 34 in the higher-dose group already had some abnormality recorded at that baseline point. For vision, 45 and 35 participants respectively had an abnormality noted. For neurological or psychiatric assessments recorded as unexpected medical events during the study, 63 participants in the lower-dose group and 25 in the higher-dose group were reported in one category, and 44 and 38 respectively in another. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02410772 · results posted 28 September 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02410772) enrolled 2,516 people across three groups, each receiving a different antibiotic combination for tuberculosis (TB). The trial was testing whether two shorter, 17-week treatment regimens — one substituting a drug called rifapentine for the standard drug rifampin (Regimen 2), and another that also swapped in a drug called moxifloxacin (Regimen 3) — could perform comparably to the standard 26-week TB treatment (Regimen 1). The main things being measured were how many people were free of TB disease 12 months after starting treatment, and how many experienced serious side effects during treatment. The reported data shows that, looking at the "favourable" outcome (being TB disease-free at 12 months) in the main analysis group, 656 out of 768 participants in the standard regimen group had a favourable result, compared with 645 out of 784 in the Regimen 2 group and 668 out of 791 in the Regimen 3 group. The reported data also shows that "unfavourable" outcomes (such as TB returning or treatment failing) were recorded for 112 participants in the standard group, 139 in Regimen 2, and 123 in Regimen 3. Regarding serious side effects (graded as severe or worse), 159 out of 666 participants in the standard group experienced them, compared with 119 out of 716 in Regimen 2 and 159 out of 687 in Regimen 3. As a secondary measure, the number of participants whose TB bacteria were no longer detectable in sputum (mucus) at eight weeks was 523 in the standard group, 616 in Regimen 2, and 641 in Regimen 3. The median time to that point of undetectable bacteria was reported as 8.14 weeks across all three groups. The number of people who stopped their assigned treatment early for reasons other than being deemed ineligible was 61 in the standard group, 37 in Regimen 2, and 55 in Regimen 3. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01751568 · results posted 21 December 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 40 children in total, split across three age groups: 13 children aged 2 to under 6 years (Cohort 1), 14 children aged 6 to under 12 years (Cohort 2), and 13 infants aged 4 weeks to under 2 years (Cohort 3). All of these children were already being treated for tuberculosis (TB). The trial was studying a HIV medicine called raltegravir, and it was measuring two things: how the drug moved through the children's bodies (called pharmacokinetics — essentially, how much of the drug was in the bloodstream and for how long), and how many children experienced serious unwanted reactions that were thought to be linked to the drug. The reported data shows that, when it came to serious unwanted reactions, 1 child in Cohort 1 and 1 child in Cohort 2 each experienced an adverse event (an unwanted health event) rated as serious (Grade 3 or above) that was considered at least possibly linked to raltegravir; no children in Cohort 3 had such an event. One child in Cohort 2 stopped taking the study drug permanently because of such a reaction; no children in the other two cohorts did. The reported data also shows that no children in any group experienced a life-threatening (Grade 4) reaction or death considered linked to raltegravir. Regarding how the drug moved through the body, the reported average amount of drug in the bloodstream over 12 hours was 12.8 h·mg/L for Cohort 1, 17.2 h·mg/L for Cohort 2, and 14.6 h·mg/L for Cohort 3. The reported average drug level remaining in the blood at the 12-hour mark was 101.8 ng/mL for Cohort 1, 101.2 ng/mL for Cohort 2, and 47.3 ng/mL for Cohort 3 (ng/mL means nanograms — a very tiny unit of measurement — per millilitre of blood). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01859923 · results posted 23 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT01859923) enrolled 37 children and teenagers in total, split into four age groups: 7 participants aged 12–17, 6 aged 6–11, 12 aged 3–5, and 12 aged from birth to 2 years. All participants received the study medicine, delamanid. The trial was primarily measuring a range of safety-related observations — including any medical events that happened after taking the medicine, physical examination findings, vital signs (such as weight, heart rate and blood pressure), heart-rhythm readings (ECGs), and blood and urine test results. It also measured how the body processed the medicine (known as pharmacokinetics). The reported data shows that every single participant across all four age groups — all 37 who started the trial — experienced at least one medical event after receiving the medicine. Regarding physical examinations, the numbers with findings flagged as abnormal by the investigator varied by group and by the specific check being looked at. For vital signs, the reported data shows that notable changes in weight were seen in a small number of participants across some groups, and larger numbers — 4 out of 7 in the oldest group, and 10 out of 12 in each of the two youngest groups — had other vital sign readings flagged. For ECG heart-rhythm readings and laboratory (blood and urine) tests, smaller numbers of participants in various groups had results flagged as clinically significant. For how the body handled the medicine, the reported data shows two pharmacokinetic estimates: a central clearance figure of 18.1 litres per hour and an inter-compartmental clearance of 105 litres per hour, though the data was reported for the group as a whole rather than broken down by age. It is worth noting that 2 participants did not complete the trial — one each from the 3–5 and birth-to-2 age groups — though the reason for not completing was not reported in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02532036 · results posted 31 August 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02532036) enrolled a very small number of participants — just two people were placed in the "Starter Group," and no participants were enrolled in the secondary group called "Group A." Both participants in the Starter Group completed the study. The trial was measuring adverse events (that is, any unwanted or unexpected health occurrences) following vaccination, tracked over six months using diary cards and clinic visits. It also aimed to look at certain laboratory markers related to the immune system, using blood samples and samples collected from the lungs. The reported data shows that for the primary outcome — adverse events — 2 participants were measured, which matches the total number enrolled in the Starter Group. No further breakdown of the types or number of adverse events experienced was included in the submitted results data. For the secondary outcome, which involved laboratory tests on blood and lung fluid samples to assess immune system activity, no measurements or numerical results were reported to ClinicalTrials.gov, so those figures are not available. It is worth noting that with only two participants, this was an extremely small study, and the results data submitted is very limited in detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03086213 · results posted 7 May 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people in total — 24 in a paravertebral nerve block group and 24 in an intercostal nerve block group. All 48 participants completed the trial with no dropouts. The trial was comparing two types of nerve-blocking procedures used during surgery, and it measured how the body responded by tracking certain substances in the blood (an inflammatory marker called Interleukin-6 and a stress hormone called cortisol) at multiple points during the operation. It also tracked heart rate, blood pressure, blood oxygen and carbon dioxide levels, and any complications related to the needle insertion procedure. The reported data shows that Interleukin-6 levels (a marker of inflammation, measured in pg/L) were recorded at four time points during surgery. In the paravertebral group the readings were 33, 39, 44, and 47 pg/L, while in the intercostal group they were 35, 42, 53, and 54 pg/L. For cortisol (a stress hormone, measured in ng/mL), the paravertebral group recorded 120, 208, 258, and 267 ng/mL across the four time points, compared with 125, 221, 290, and 318 ng/mL in the intercostal group. For blood pressure (mean arterial pressure in mmHg), the paravertebral group recorded 79, 85, 72, and 78, while the intercostal group recorded 80, 86, 85, and 80. Heart rate readings (beats per minute) for the paravertebral group were 78, 84, 81, and 78, compared with 79, 85, 92, and 80 for the intercostal group. Blood gas readings showed oxygen levels of 95.2 vs 96.2 and carbon dioxide-related readings of 51.1 vs 47.3 (reported in cmH2O) for the two groups respectively. Regarding procedure-related complications, the reported data shows 2 participants in the paravertebral group and 3 in the intercostal group experienced one type of complication, and 2 participants in each group experienced another — though the data does not specify what each complication was. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02651259 · results posted 6 May 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 50 pregnant women across two groups: 25 women who joined during their second trimester of pregnancy (Cohort 1) and 25 women who joined during their third trimester (Cohort 2). All 50 women completed the study with no dropouts. The trial was measuring how the body processes two tuberculosis-prevention medicines — rifapentine (RPT) and isoniazid (INH) — during pregnancy, by tracking how quickly the medicines move through the body and how they are broken down. It also recorded certain unwanted health events (called adverse events) that occurred during the study period. The reported data shows several measurements related to how the body handled rifapentine. The rate at which the drug was cleared from the body (a measure of how quickly the body removes it) was reported as 1.40 litres per hour for the second-trimester group and 1.50 litres per hour for the third-trimester group. A breakdown product of rifapentine (called desacetyl-rifapentine) was cleared at a rate of 2.82 litres per hour across all participants combined. The rate at which the medicine was absorbed into the body was reported as 1.43 per hour, and the estimated space the drug distributed into within the body was reported as 30.1 litres, both measured across all participants together. Regarding unwanted health events, the reported data shows that no participants in either group experienced a serious adverse event considered related to the study medicines. As for moderate (Grade 2) adverse events considered related to the study medicines, 4% of women in the second-trimester group reported one, while 0% of women in the third-trimester group did. It is important to note that this trial was not designed to draw broad conclusions about the wider population, and any figures not listed above were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04150224 · results posted 28 February 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 60 people in total, split across six groups of 10 (labelled Cohorts 1A through 5). All 60 participants completed the study. The trial was testing a drug called PBTZ169, and the main things it was measuring were the number of unwanted health events (called adverse events, or AEs) that occurred, and how many participants experienced them. Secondary measures looked at changes in vital signs (such as blood pressure and heart rate), heart-tracing (ECG) results, blood and urine test results, and physical examination findings. The reported data shows that across the dose groups, the number of adverse events ranged from 2 to 9 per group (with Cohorts 1 combined and Cohort 5 each recording 9, Cohort 2 recording 4, Cohort 3 recording 5, and Cohort 4 recording 2). The number of participants who experienced at least one adverse event ranged from 2 to 6 across the groups. No serious adverse events (a more severe category of health event) were reported in any group. For the secondary measures, no clinically significant changes in vital signs were recorded for most groups, though 3 cases were noted in Cohort 1B in one reporting period. Clinically significant ECG findings were noted in 1 participant in Cohort 1A and 1 in Cohort 3 in one period, and 1 participant in Cohort 1B in another period. Abnormal laboratory test results were noted in 1 participant in Cohort 1A, 2 in Cohort 1B, and 2 in Cohort 5 across different reporting periods. No clinically significant findings were recorded during physical examinations in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02082340 · results posted 18 February 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 392 people in total — 194 in the intervention arm (the group receiving the study approach) and 198 in the control arm (the comparison group). Nearly all participants finished the trial, with just one person in each group not completing it. The trial was measuring treatment success rates for tuberculosis (TB), as defined by the World Health Organization (WHO), along with several other areas including knowledge about TB, stigma toward TB patients, family support, treatment adherence, and depression in TB patients. The reported data shows that, when looking at the primary measure — TB treatment success — 184 out of 198 participants in the control arm and 176 out of 194 participants in the intervention arm met the WHO definition of treatment success. This definition covers people who were either confirmed clear of TB bacteria by testing, or who completed their full course of treatment without signs of failure (even if final test results were not available). For the six secondary outcome measures — covering knowledge, stigma, family support, adherence, and depression — the data was not reported in the results submitted to ClinicalTrials.gov, so no numbers are available for those areas. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02153528 · results posted 13 February 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 701 people with tuberculosis (TB) — 348 in a group receiving the standard TB treatment and 353 in a group receiving double the usual dose of rifampicin (one of the main TB medicines). The trial was measuring two main things: how many people had a poor treatment outcome (such as the TB coming back, treatment failing, dropping out of treatment, or dying), and how many people developed serious liver problems during treatment. The reported data shows that, for poor treatment outcomes, the numbers were broadly similar between the two groups. Deaths during treatment were reported for 8 people in the standard treatment group and 8 in the double rifampicin group. Treatment failure (TB still detected in sputum at five months or later) was reported for 11 people in the standard group and 5 in the double rifampicin group. Cases where treatment had to be stopped or changed were reported for 8 in the standard group and 12 in the double rifampicin group. Relapses (TB returning after treatment) were reported for 6 in the standard group and 3 in the double rifampicin group. Successful outcomes were reported for 310 people in the standard group and 319 in the double rifampicin group. For serious liver problems (a key safety measurement), the reported data shows 7 cases in the standard treatment group and 3 cases in the double rifampicin group. For the secondary measurements, the reported data shows that among participants whose TB showed signs of resistance to rifampicin at the start, adverse outcomes were reported in 2 people in the standard group and 1 in the double rifampicin group. The trial also looked at whether a sputum test at two weeks could predict who would later relapse — the reported data shows zero relapses among those who tested negative on either of the two sputum testing methods used, though this result covers only the double rifampicin group. No cases of newly acquired rifampicin resistance were reported in either group among those who failed or relapsed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02378207 · results posted 18 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people across four groups. Twenty-four participants received a vaccine called H4:IC31, 24 received a vaccine called H56:IC31, 24 received a BCG vaccination (a well-known tuberculosis vaccine), and 12 received a saltwater (saline) control injection. The trial was measuring two main things: how many participants experienced side effects or adverse events after their injections, and whether participants showed a change in their immune system's response to tuberculosis-related proteins compared to their starting level. By the end of the study, most participants completed the trial — all 24 in the H4:IC31 group, 21 of 24 in the H56:IC31 group, 22 of 24 in the BCG group, and 11 of 12 in the control group. The reported data shows that when it came to adverse events (unwanted health events recorded after vaccination), 22 out of 24 participants in the H4:IC31 group, 20 out of 24 in the H56:IC31 group, 24 out of 24 in the BCG group, and 10 out of 12 in the control group had at least one adverse event recorded. Regarding the immune response measurements — specifically looking at whether the body's immune cells showed a reaction to tuberculosis proteins compared to the starting point — the reported data shows that 40% of H4:IC31 participants and 45% of H56:IC31 participants showed a response to certain proteins, while 0% of the BCG group and 0% of the control group did for that same measurement. For other protein targets measured, smaller percentages of participants across all groups showed responses, with figures ranging from roughly 0% to 22% depending on the group and the specific protein tested. The secondary outcome measures (such as antibody responses, gene activity changes, and other immune cell measurements) were listed in the trial registration but no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02375698 · results posted 18 November 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02375698) involved 22 people in total — 16 received the experimental vaccine called H56:IC31 (at a dose of 5/500) and 6 received a placebo (an inactive substance used for comparison). The trial was looking at two main things: first, how many participants experienced unwanted health events (called adverse events) or serious adverse events after receiving the injections; and second, whether the vaccine produced any measurable change in the way participants' immune cells responded to two tuberculosis-related proteins, Ag85A and ESAT-6. The reported data shows that when it came to adverse events, 14 out of 16 participants in the vaccine group and all 6 out of 6 in the placebo group had at least one adverse event recorded. No serious adverse events were reported in either group. For the secondary outcome — measuring immune cell responses to the two TB proteins — the reported data shows a small average percentage change from the starting point. For the protein Ag85A, the vaccine group showed a mean change of +0.014% compared to −0.029% in the placebo group. For the protein ESAT-6, the vaccine group showed a mean change of +0.026% compared to −0.018% in the placebo group. These figures represent very small numerical differences in a laboratory measurement of immune cell activity. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00810446 · results posted 2 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 72 participants in Japan who were taking MYCOBUTIN Capsules (rifabutin), an antibiotic used to treat certain bacterial infections. All 72 participants completed the study. The trial was a surveillance study — meaning it was set up to monitor and record what happened to people already receiving the medicine in routine care, rather than comparing it against a placebo or another treatment. The main things being tracked were unwanted reactions that doctors attributed to the medicine, and how participants' conditions changed over time. The reported data shows that 16 out of 72 participants experienced an adverse drug reaction (an unwanted medical event that the treating doctor linked to the medicine). Of those 16, 7 were classed as serious adverse drug reactions — meaning they led to outcomes such as hospitalisation, life-threatening situations, or other significant consequences. The reported data also shows that 7 participants experienced a reaction that was not already listed in the Japanese product information for this medicine (described as "unknown" reactions). When the results were broken down by gender, all 16 reported reactions occurred in one gender group, with 0 in the other; however, the data as submitted does not label which group was which, so those specific details cannot be described further here. For clinical response — meaning the proportion of participants whose doctors judged their condition to have "markedly improved" or "improved" — the reported figure was 80.6% of those assessed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02193776 · results posted 26 July 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 240 people with tuberculosis (TB) across four treatment groups. Three groups had drug-sensitive TB (DS-TB) and one group had drug-resistant TB (MDR-TB). The trial was measuring how quickly the TB bacteria in participants' sputum (mucus coughed up from the lungs) were being reduced over eight weeks of treatment. This was tracked using a lab test that measures how long it takes for any remaining bacteria to grow in a special liquid — a longer growth time suggests fewer bacteria are present. The trial compared three different experimental drug combinations against a standard TB treatment. The reported data shows the primary measurement — the daily rate of change in bacteria over the 56-day treatment period — was 4.878% per day for the first DS-TB experimental group (bedaquiline loading dose plus PA-824 plus pyrazinamide), 5.182% per day for the second DS-TB experimental group (bedaquiline 200 mg plus PA-824 plus pyrazinamide), 4.046% per day for the standard DS-TB treatment group (isoniazid, rifampicin, pyrazinamide, and ethambutol), and 5.194% per day for the MDR-TB experimental group (bedaquiline plus moxifloxacin plus PA-824 plus pyrazinamide). The reported data also shows the number of participants who experienced adverse events (unwanted medical occurrences) during the trial. Overall adverse events were recorded in 50, 45, 44, and 57 participants across the four groups respectively. Drug-related adverse events were recorded in 38, 29, 29, and 46 participants respectively. One participant in each of the first three groups, and no participants in the MDR-TB group, experienced an adverse event that was recorded as fatal. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01424670 · results posted 15 May 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 511 adults with multidrug-resistant tuberculosis (a form of TB that does not respond to the most common antibiotics). Participants were split into two groups: 341 people received delamanid plus an optimised background regimen (OBR — a personalised combination of other TB medicines), and 170 people received a placebo (an inactive dummy tablet) plus OBR. The trial ran for up to 30 months and was mainly measuring how quickly participants' sputum (phlegm) tests stopped showing signs of TB bacteria — a process called sputum culture conversion, or SCC. The reported data shows that, for the primary measure, the middle point (median) time for sputum tests to turn negative was 51 days in the delamanid group and 57 days in the placebo group. For a secondary measure looking at the proportion of people whose sputum tests turned negative, at 2 months this was 132 out of 341 participants in the delamanid group and 54 out of 170 in the placebo group; at 6 months it was 198 out of 341 and 87 out of 170 respectively. When doctors assessed overall treatment outcomes at the end of the full treatment period (around 24 months), the reported data shows 182 participants in the delamanid group and 85 in the placebo group had what were classified as favourable outcomes; 42 and 16 respectively had unfavourable outcomes; and 2 in the delamanid group and none in the placebo group had an outcome in a third, separate category. The reported data also shows that 3 participants in the delamanid group developed resistance to delamanid during the trial, while none in the placebo group did (as they were not taking delamanid). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03075410 · results posted 19 April 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03075410) studied an experimental medicine called GSK3036656 across two parts. Part A involved a small number of healthy volunteers — across six groups, each group had only 1–2 people — who received different doses of the medicine (5 mg, 15 mg, or 25 mg) or a dummy treatment (placebo) across several 14-day periods, including some doses taken with food. Part B involved 19 people split across three groups: 4 received placebo, 7 received repeated doses of 5 mg, and 8 received repeated doses of 15 mg. The trial was measuring things like unwanted medical events (called adverse events), heart trace (ECG) readings, vital signs such as blood pressure and pulse, and blood and urine test results — all to track what happened to participants over the course of the study. The reported data shows that in Part A, non-serious adverse events were recorded in 1 participant each in the placebo, 5 mg, and 15 mg groups, and in 3 participants in the 25 mg group, and 1 participant in the fed 5 mg group. No serious adverse events were reported in Part A. In Part B, non-serious adverse events were recorded in 2 participants in the repeat 5 mg group and 1 participant in the repeat 15 mg group, with none in the placebo group; again, no serious adverse events were reported. For ECG readings in Part A, abnormal findings were reported in 2 participants in the placebo group and 1 participant in the 5 mg group, with none in the other groups. The reported data for many of the other outcome measures — including full vital signs, laboratory results, and other ECG details — was not completely available in the structured results as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02342886 · results posted 26 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02342886) enrolled 284 people with tuberculosis (TB) across five treatment groups. Four groups had standard drug-sensitive TB (DS-TB) and one smaller group had drug-resistant TB (MDR-TB). The trial was testing whether shorter experimental treatment combinations — using medicines called moxifloxacin, PA-824 (at two different doses), and pyrazinamide — could be compared to the standard six-month TB treatment. The main thing being measured was how many people in each group either did not clear the infection, relapsed (the TB came back after treatment ended), or experienced a clear worsening of their condition by 12 months from the start of treatment. The reported data shows the primary outcome results across two analysis groups — one broader group (called the "Modified Intent to Treat" group, meaning most people who started the trial) and one stricter group (called the "Per Protocol" group, meaning those who followed the treatment plan most closely). In the broader analysis, the number of participants with an unfavourable outcome (treatment failure, relapse, or clinical failure) at 12 months was: 19 out of 38 assessed in the 4-month PA-824 100 mg group; 15 out of 46 in the 4-month PA-824 200 mg group; 13 out of 43 in the 6-month PA-824 200 mg group; 8 out of 52 in the standard treatment group; and 1 out of 10 in the drug-resistant TB group. In the stricter analysis, the reported numbers of unfavourable outcomes were: 14 out of 38; 11 out of 46; 4 out of 43; 1 out of 52; and 0 out of 10, respectively. No other outcome measure data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00810407 · results posted 7 March 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 594 participants, all of whom received a medication called Mycobutin (rifabutin). The vast majority — 588 people — completed the study, while 6 did not. The trial was conducted in Japan and was set up to track two main things: any unwanted medical events that doctors considered to be linked to taking Mycobutin, and how often doctors judged the treatment to be clinically effective for each patient's condition. The reported data shows that out of 594 participants, 387 experienced at least one unwanted medical event that their doctor attributed to Mycobutin. Of those, 113 were counted in a separate measurement (the data does not fully explain how this second figure was defined separately from the first). Additionally, 71 participants experienced treatment-linked events that were considered unexpected based on the Japanese prescribing information for the medication. When the reported data breaks down these events by patient characteristics, the largest single group was 312 participants who had a particular diagnosis (the specific diagnosis labels were not included in the data provided). By gender, 264 were male and 123 were female. By age group, 235 fell into one middle age bracket, 149 into another, with very small numbers (1 and 2) in the youngest and oldest groups respectively. The reported data also shows that doctors rated Mycobutin as clinically effective for approximately 62.7% of participants who could be assessed for effectiveness — meaning that out of those assessable patients, roughly 6 in 10 were judged by their doctor to have responded. It is important to note that this is simply the number doctors recorded; it does not on its own tell us how that compares to no treatment or a different treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01098474 · results posted 27 November 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 300 young children across six groups. Three groups received different doses of an experimental vaccine called SB692342 (two doses, one dose, or a comparison vaccine called Menjugate). The other three groups received a related experimental vaccine, SB692392, given alongside routine childhood vaccines (Tritanrix, Prevnar, and Polio Sabin), again at two doses, one dose, or with routine vaccines only as a comparison. The trial was primarily measuring how often children experienced severe reactions — such as serious pain, redness, swelling, fever, drowsiness, or fussiness — after their vaccinations. The reported data shows that for the three groups receiving SB692342 or the Menjugate comparison vaccine, zero participants in any group recorded a severe ("Grade 3") local reaction such as pain, redness, or swelling, and zero recorded a severe general symptom such as high fever or drowsiness. For the groups receiving SB692392 alongside routine vaccines, the reported data shows that a small number of children — between zero and six participants depending on the group and dose — experienced severe local reactions at various time points, and zero children in any of those three groups recorded a severe general symptom. Regarding unexpected medical events that were not specifically watched for, the reported data shows these were recorded in between 14 and 28 participants per group across all six groups. One serious medical event (defined as something life-threatening, requiring hospitalisation, or causing lasting harm) was reported in the SB692392 two-dose plus routine vaccines group, and one was reported in the Menjugate comparison group; no serious events were reported in the remaining four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01494038 · results posted 20 November 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01494038) enrolled 956 pregnant women in total — 477 in Arm A, who received isoniazid (INH, a tuberculosis-preventive medicine) immediately, and 479 in Arm B, who received it on a deferred basis. The trial was primarily measuring how often serious unwanted health events occurred — specifically, side effects rated as severe or higher that were linked to the study treatment, or side effects serious enough to cause a participant to stop taking the treatment altogether. A number of pregnancy and birth-related outcomes were also tracked as secondary measures. The reported data shows that the rate of these serious treatment-related events was very similar between the two groups: 15.03 events per 100 person-years (a way of counting how many events happened relative to how long participants were followed) in the immediate treatment group, and 14.93 events per 100 person-years in the deferred treatment group. For the secondary outcomes, the reported data shows that fetal deaths (including stillbirths and miscarriages) were recorded for 17 mothers in Arm A and 9 in Arm B; premature births occurred in 48 mothers in Arm A and 40 in Arm B; low birth-weight babies were recorded for 62 mothers in Arm A and 46 in Arm B; and congenital anomalies (birth defects) were noted for 10 mothers in Arm A and 6 in Arm B. The data for babies recorded as small for their gestational age was not reported in the submitted results. It is worth noting that these numbers describe what was observed and counted in this specific study group — they do not on their own tell us whether any differences between the two arms are meaningful or due to chance, and no treatment recommendation should be drawn from them alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02412436 · results posted 25 September 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 62 participants, all of whom received a contraceptive injection called depot medroxyprogesterone acetate (DMPA — a hormonal contraceptive given as a shot). Forty-four participants completed the study, while 18 did not finish. The trial was measuring levels of the DMPA hormone and a natural body hormone called progesterone in participants' blood over 12 weeks. The reason for tracking these levels is that DMPA is understood to suppress ovulation (the release of an egg) when its concentration in the blood stays at or above a certain threshold (0.1 ng/mL — a unit measuring how much of the substance is in the blood). The reported data shows that at the 12-week mark, 11.9% of participants had DMPA blood levels that had dropped below that 0.1 ng/mL threshold. For the earlier time points — weeks 2, 4, 6, 8, and 10 — the reported figures show that 0% of participants were below the threshold at weeks 2, 4, 6, and 8, rising slightly to 2.4% at week 10. Separately, the reported data shows that 0% of participants had progesterone levels above 1 ng/mL at week 12 (a level that can indicate the body may be moving toward ovulation). The reported minimum DMPA blood concentration recorded across the study period was 0.33 ng/mL, and a summary measure of overall drug exposure across the 12 weeks (called the "area under the curve") was reported as 7.63 ng·week/mL. These figures are descriptive measurements of hormone levels in blood at specific points in time; they tell us what was detected in this group of participants under the study conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01262976 · results posted 17 September 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 240 people across six groups of 40 participants each. The groups included people living with HIV who were on highly active antiretroviral therapy (labelled "HA"), people living with HIV who were treatment-naive (labelled "TN" — meaning they had not yet started HIV medication), and people without HIV. Within each of these three categories, participants were randomly assigned to receive either an experimental vaccine candidate called GSK692342 or a placebo (an inactive injection). The trial tracked participants for up to three years and was primarily measuring how often participants experienced certain types of reactions or medical events after their injections. The reported data shows that very few participants experienced the most severe ("Grade 3") local injection-site reactions such as serious pain or swelling. Across all six groups, only 1–2 participants in some groups receiving GSK692342 reported such reactions, and none were reported in any placebo group. Similarly, severe general symptoms like fatigue, headache, or fever were reported in only 1 participant each in two of the groups. For more general unexpected medical events serious enough to prevent normal daily activity ("Grade 3 unsolicited adverse events"), the reported numbers were higher across all groups — ranging from 13 to 35 participants per group — and these numbers were broadly similar between the GSK692342 and placebo groups within each category. Serious adverse events (those involving hospitalisation, being life-threatening, or causing lasting disability) were reported in 1 participant in one HIV-positive/HA GSK692342 group and 2 participants in one HIV-positive/TN GSK692342 group, and none in the placebo groups or HIV-negative groups. For blood test results, the reported data shows that no participants across any group reached the most concerning levels (Grade 3 or 4) for the blood and organ markers that were tested, with one minor exception of a single participant in the HIV-negative placebo group at one measurement point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01601626 · results posted 13 February 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 71 adults in total across three groups, all of whom were being treated for both HIV and tuberculosis (TB) at the same time. There were 24 people in Group A (standard-dose LPV/r with rifabutin), 24 in Group B (double-dose LPV/r with rifampicin), and 23 in Group C (standard-dose LPV/r plus raltegravir with rifabutin). These are all combinations of HIV and TB medicines. The trial was measuring how well each combination kept HIV levels low in the blood and how the TB responded to treatment, over about 48 weeks. The researchers noted upfront that because the trial was relatively small, no formal statistical comparisons between the groups were made. The reported data shows that for the main outcome — the proportion of participants whose HIV level in the blood dropped below 400 copies per millilitre by week 48 — the figures were 58.3% in Group A, 66.7% in Group B, and 60.9% in Group C. Using a stricter measure of HIV suppression (below 50 copies per millilitre), the reported figures were 45.8%, 54.2%, and 56.5% respectively. For TB-related results, the reported data shows that the proportion of participants whose TB sputum (mucus) test turned negative by week 8 was 87.5% in Group A, 81.8% in Group B, and 70.0% in Group C. TB treatment failure — meaning TB bacteria were still detected after 16 weeks despite taking medication — was reported as 0% across all three groups. TB coming back after initial clearance was reported as 0% in Group A, and approximately 4% in both Groups B and C, with no drug-resistant TB recorded among those cases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01785186 · results posted 20 September 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01785186) enrolled 365 people across five treatment groups, all of whom were being treated for tuberculosis (TB). The groups were given different combinations of TB medicines, including combinations involving drugs called rifampicin, isoniazid, pyrazinamide, moxifloxacin, SQ109, and ethambutol. The main thing the trial was measuring was how many days it took for participants' sputum (mucus coughed up from the lungs) to test negative for TB bacteria on two tests in a row — a sign that bacteria were no longer being detected in the sample. Most participants completed the study, with between 5 and 6 people in each group not finishing. The reported data shows that the number of days to reach two consecutive negative sputum tests varied across the five groups. The group called "Arm 1 (R35)" recorded a median (the middle value when all results are lined up) of 48 days, while the HRZQ group recorded 63 days, HR20ZQ recorded 66 days, HR20ZM recorded 55 days, and the HRZE group recorded 62 days. For the secondary outcome looking at how many participants experienced unwanted or unexpected health events (called adverse events), the reported numbers of participants who experienced any adverse event ranged from 42 to 92 across the five groups, and a smaller number — between 4 and 6 per group — experienced events considered possibly related to the study drugs. Some other planned measurements, such as detailed analysis of how the drugs moved through the body over time and their relationship to bacteria levels, were either not reported in full or had no data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01408914 · results posted 13 July 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people with tuberculosis (TB), divided equally into three groups of 60. Each group received a different daily dose of the antibiotic rifampin — either 10 mg/kg, 15 mg/kg, or 20 mg/kg of body weight. The trial was measuring how the drug was absorbed into the body at each dose, and also tracking sputum (phlegm) test results and the occurrence of certain unwanted side effects over the first eight weeks of treatment. By the end of the study, 48 participants in the 10 mg/kg group, 48 in the 15 mg/kg group, and 47 in the 20 mg/kg group had completed the trial. The reported data shows that the main thing being measured was a ratio comparing how much of the drug was present in the bloodstream over time against a laboratory measure of how much drug was needed to act against the TB bacteria. The reported ratios were 115.7 for the 10 mg/kg group, 201.9 for the 15 mg/kg group, and 284.4 for the 20 mg/kg group — meaning this ratio increased as the dose went up. For the secondary outcomes, the reported data shows that at eight weeks, 46 out of 60 participants in the 10 mg/kg group, 44 out of 60 in the 15 mg/kg group, and 45 out of 60 in the 20 mg/kg group had a negative sputum test for TB. Regarding unwanted events of moderate severity or higher that were considered related to rifampin, 26 participants in the 10 mg/kg group, 31 in the 15 mg/kg group, and 23 in the 20 mg/kg group experienced at least one such event during the treatment period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01589497 · results posted 4 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 69 adults with tuberculosis across four treatment groups, each receiving a different combination of antibiotics over a study period. The four groups were labelled RHZE-RHZE, RHZE-RZE, RHZE-RMZE, and RZE-RZE — these names refer to different combinations of tuberculosis medicines given in two phases. The trial was measuring how quickly the amount of tuberculosis bacteria in participants' sputum (phlegm) changed over the first 14 days of treatment. Between 15 and 17 participants completed the study in each group, with one person in each group not finishing. The reported data shows that the primary measurement — the average daily reduction in bacteria in sputum over 14 days — was 0.134 for the RHZE-RHZE group, 0.096 for RHZE-RZE, 0.136 for RHZE-RMZE, and 0.119 for RZE-RZE (measured on a specialised scale used to count bacteria). The reported data also shows results for shorter time windows. In the first two days, the daily reduction figures were 0.255, 0.385, 0.111, and 0.034 for the four groups respectively, and from day 2 to day 14, the figures were 0.143, 0.093, 0.123, and 0.104. A second way of measuring bacterial activity — called "time to positivity," which refers to how long it took a lab test to detect bacteria — also changed over the study period, with reported shifts of around 11–13 hours per day over the full 14 days and around 25–31 hours per day in the first two days across all groups. The trial organisers noted that no formal statistical comparison between the groups was conducted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00621322 · results posted 3 February 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people across six groups. There was a control group (10 people) and one group receiving a formulation called GSK692342\_F1 (10 people), with four further groups receiving different formulations or doses of the same investigational vaccine — GSK692342\_F2, F3, F4D1, and F4D2 — with 40 people in each of those groups. The trial was measuring reactions and medical events that participants experienced after receiving their vaccination, including reactions at the injection site, general symptoms across the body, any other unexpected medical events, serious medical events, and changes in blood test results. The reported data shows the following counts of people who experienced symptoms or events. For local reactions at the injection site (such as pain, redness, or swelling), the numbers reporting any such symptom were: 8 out of 10 in the control group, 3 out of 10 in the F1 group, 35 out of 40 in F2, 33 out of 40 in F3, 33 out of 40 in F4D1, and 32 out of 40 in F4D2. Severe local reactions (those that stopped normal daily activities or spread more than 50mm from the injection site) were reported by 0 participants in most groups, with 1 person in the F4D2 group. For general body symptoms (such as tiredness, headache, or fever), the numbers reporting any such symptom were 1, 1, 4, 5, 7, and 3 across the six groups respectively, with no severe general symptoms reported in any group. For other unexpected medical events, between 7 and 33 people per group reported at least one such event, with severe events related to vaccination reported in only 1 person each in the F2 and F3 groups. Serious medical events — meaning those requiring hospitalisation or considered life-threatening — were reported in 2 people in the F2 group and 2 people in the F4D1 group, and none in the remaining groups. Blood test results outside the normal range were reported for some participants across groups, though the data as submitted does not break down which specific tests were outside normal limits for each individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00950612 · results posted 9 January 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 60 adults in total — 40 people received a candidate vaccine called GSK692342, and 20 received a placebo (an inactive injection). All 60 participants completed the study. The trial was primarily measuring physical reactions at and around the injection site, general symptoms felt after the injection, any unexpected medical events, serious medical events, and the results of blood tests tracking certain liver, kidney, and blood cell markers. The reported data shows that when it came to reactions at the injection site (such as pain, redness, or swelling), 37 out of 40 people in the GSK692342 group reported at least one such symptom, compared with 3 out of 20 in the placebo group. Severe local reactions (those preventing normal daily activity or spreading more than 50 mm from the injection site) were reported in small numbers or not at all in either group. For general symptoms like fatigue, headache, or muscle aches, the reported data shows figures ranging from 9 to 11 out of 40 in the GSK692342 group for individual symptoms, compared with 2 to 3 out of 20 in the placebo group. Nine people in the GSK692342 group and 3 in the placebo group reported other unexpected medical events. Importantly, zero participants in either group were reported to have experienced a serious adverse event (such as hospitalisation or a life-threatening occurrence). Blood test results showed the large majority of participants in both groups had readings within the normal range across the various markers checked, though the specific number varied slightly by test. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00814671 · results posted 28 September 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 153 people across three treatment groups: one group received a 450 mg daily dose of rifapentine (RPT 450, 54 people), one received a 600 mg daily dose of rifapentine (RPT 600, 51 people), and one received a 600 mg daily dose of rifampicin, a standard tuberculosis antibiotic (RIF 600, 48 people). The trial was measuring two main things: how many participants had a negative tuberculosis culture test (meaning no detectable bacteria in a lab sample) at week 8, and how many participants stopped taking their assigned treatment early. The reported data shows that, at week 8, 85% of participants in the RPT 450 group, 94% in the RIF 600 group, and 96% in the RPT 600 group had negative culture test results. Regarding stopping treatment early, 2% of participants in the RPT 450 group, 8.3% in the RIF 600 group, and 2% in the RPT 600 group discontinued their assigned treatment. For secondary measurements, the reported data shows the number of days it took for bacteria to become undetectable in lab samples: on a solid testing medium, this took an average of 37 days (RPT 450), 43 days (RIF 600), and 36 days (RPT 600); on a liquid testing medium, it took 50 days, 59 days, and 57 days respectively. The trial also measured how much of the rifapentine drug was absorbed into the bloodstream over 24 hours — the reported figures were 330 micrograms×hour/mL for the 450 mg dose and 435 micrograms×hour/mL for the 600 mg dose. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01097005 · results posted 19 September 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 466 people, all of whom received the antibiotic clarithromycin. The trial was looking at a lung condition caused by non-tuberculous mycobacteria (NTM) — a type of bacteria found in the environment that can infect the lungs. The main thing the trial measured was whether participants who initially had detectable bacteria in their system stopped testing positive for those bacteria at some point during treatment. Different numbers of participants were included in different parts of the analysis, ranging from 441 people assessed for safety-related observations down to 249 assessed for an overall clinical rating. Only 101 participants were recorded as completing the trial, while 365 did not complete it — though the reasons for this were not detailed in the reported data. The reported data shows that out of 285 participants included in the bacteria conversion analysis, 269 went from testing positive for the bacteria to testing negative at some point during treatment. For a secondary measure, investigators rated the treatment using a four-category scale for 249 participants: 217 were rated "effective," 13 "ineffective," 10 "deterioration," and 9 "impossible" (meaning a rating could not be given). Regarding whether the bacteria returned after initially clearing — known as a bacteriological relapse — the reported data shows 5 participants experienced a relapse in one group based on how long they received clarithromycin, and 0 in another duration group, though the specific durations compared were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00568854 · results posted 16 August 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people in total — 6 who had diabetes and 4 who did not. All 10 participants completed the study. The trial was looking at how the immune system responds to BCG vaccination (a vaccine most commonly known for tuberculosis prevention) in people with and without diabetes. Two things were measured: a skin reaction test done before and about five months after vaccination, and blood samples taken at regular intervals over 20 weeks to track a specific immune signal called interferon-gamma (a protein the body produces as part of an immune response). The reported data shows that, for the skin reaction test (called a tuberculin skin test), participants with diabetes had an average result of 0 mm change, while participants without diabetes had an average result of 3 mm change. For the blood-based immune signal tracking, the reported data shows that both groups — those with diabetes and those without — reached their peak immune response at the same point in time, which was 8 weeks after vaccination. It is worth noting that this was a very small study with only 10 participants across both groups, and the results as reported give a limited picture. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01165840 · results posted 21 July 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 36 participants, all of whom completed the study — no one dropped out. The trial involved a single group of participants who received dapsone, and it was designed to measure how the body processes this medicine, specifically how quickly it is cleared from the bloodstream. The reported data shows that the primary outcome measured was something called "serum clearance" — this is a way of describing how fast the body removes a medicine from the blood. For dapsone, the reported clearance figure was 2.55 litres per hour. No secondary outcome measures or additional results appear to have been submitted in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01215851 · results posted 1 April 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 85 people across six treatment groups, all of whom had tuberculosis (TB). The six groups tested different combinations of TB medicines: TMC207 alone (15 people), TMC207 with Pyrazinamide (15), PA-824 with Pyrazinamide (15), PA-824 with Moxifloxacin and Pyrazinamide (15), a standard comparison treatment called Rifafour (10), and TMC207 with PA-824 (15). The trial was measuring what researchers call "early bactericidal activity" — in plain terms, how quickly the amount of TB bacteria in participants' sputum (phlegm) changed over the first 14 days of treatment. Most participants completed both the treatment period and a follow-up period. The reported data shows the main result as a rate of daily change in the number of TB bacteria detected in sputum samples — a higher positive number means a faster daily reduction in bacteria. Over the full 14-day period, the reported rates were: TMC207 alone, 0.061; TMC207 with Pyrazinamide, 0.131; PA-824 with Pyrazinamide, 0.154; PA-824 with Moxifloxacin and Pyrazinamide, 0.233; Rifafour (the comparison group), 0.140; and TMC207 with PA-824, 0.114. The trial also measured bacterial changes over shorter windows (days 0–2, days 2–14, and days 7–14), with broadly similar patterns across those time points. A separate measure tracked how long it took bacteria to grow in a laboratory culture — the reported daily change in that growth time ranged from around 5.4 hours per day (TMC207 alone) up to about 18.5 hours per day (PA-824 with Moxifloxacin and Pyrazinamide). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01380080 · results posted 23 February 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01380080) enrolled 850 people living with HIV — 424 in "Arm A" (called the Empiric group) and 426 in "Arm B" (called the IPT group). Around 339 and 343 people respectively completed the study. The trial was comparing two different approaches to managing tuberculosis (TB) preventive treatment in people with HIV, and it measured things like the chances of dying, becoming seriously ill, and how well HIV was being controlled in the blood over time. The reported data shows that the main outcome — an estimate of the chance of dying or having an unknown vital status by 24 weeks — was 5.2 out of every 100 people in both groups. For death alone by 24 weeks, the figures were 4.8 per 100 in the Empiric group and 5.2 per 100 in the IPT group. Looking at the combined chance of dying or having a serious HIV-related illness (known as AIDS progression) by 24 weeks, the reported figures were 17.1 per 100 in the Empiric group and 12.5 per 100 in the IPT group. By 96 weeks, the reported chance of a first serious HIV-related illness alone was 16.6 per 100 in the Empiric group and 11.3 per 100 in the IPT group. The reported data also shows that the proportion of participants with very low levels of HIV in their blood (below 400 copies per millilitre, meaning the virus was being suppressed) grew over time in both groups, reaching around 84–87% in the Empiric group and 85–89% in the IPT group at later time points. A measure of immune system health (CD4+ T-cell count — a type of white blood cell that HIV attacks) also appeared to rise over time in both groups, from around 18–19 cells per cubic millimetre at the start to 172–176 cells per cubic millimetre by the end, though the reported data does not break down all time points with full detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01322841 · results posted 18 December 2015

  According to the results reported on ClinicalTrials.gov, this trial involved 2,239 children attending paediatric clinics, split into two groups: 1,116 children whose doctors used a computer-based screening tool called the CHICA Diagnosis Module, and 1,123 children whose doctors used a version of the system without the active screening feature (called the "placebo" group). The trial was measuring whether the computer tool helped doctors identify children who might have certain medical conditions — specifically, it looked at how many children were flagged as possibly having one of the conditions being screened for, and how many then received a formal diagnosis. The reported data shows that in the group using the active CHICA tool, 17.5% of children screened positive for one of the conditions being studied, compared with 3.1% in the placebo group. A second set of figures for the same primary measure shows 1.8% versus 0.8% respectively, though the data as submitted does not clearly label what distinguishes these two sets of numbers within the primary outcome. For the secondary outcome — the percentage of children who went on to receive a formal diagnosis — the reported data shows 0.3% in the CHICA group and 0% in the placebo group, with a second pair of figures showing 0.2% in the CHICA group and 0% in the placebo group. Again, the submitted data does not explain what separates these two sets of figures, so their precise meaning cannot be confirmed from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01151189 · results posted 26 August 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 650 HIV-positive African adults who did not have active tuberculosis (TB) at the time — 326 in the placebo group and 324 in the vaccine group (MVA85A/AERAS-485, an experimental TB vaccine). The trial was primarily measuring how often adverse events (that is, any unwanted health events that were recorded during the study) occurred in each group. It also looked at the number of TB cases that developed, as well as changes in two blood measurements: CD4+ lymphocyte counts (a type of immune cell often used to monitor HIV) and HIV viral load (the amount of HIV virus detectable in the blood). The reported data shows that adverse events were recorded very frequently in both groups — 96.0% of placebo participants and 99.1% of vaccine participants had at least one adverse event reported. For TB cases, 9 participants in the placebo group and 6 in the vaccine group developed TB during the study. Regarding immune cell counts (CD4+), the reported data shows broadly similar figures between the two groups both before and after vaccination, whether or not participants were on HIV treatment (antiretroviral therapy). For HIV viral load in participants not on HIV treatment, the reported starting figures were approximately 6,919 copies/mL (placebo) and 9,617 copies/mL (vaccine), shifting to around 9,090 and 6,438 copies/mL respectively at follow-up. In those on HIV treatment, viral loads were very low in both groups throughout, at roughly 26–29 copies/mL, which is consistent with controlled HIV. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02329730 · results posted 9 April 2015

  According to the results reported on ClinicalTrials.gov, this trial tested a skin-test substance called ESAT6-CFP10, which is being investigated as a way to detect tuberculosis (TB). The trial enrolled 148 participants in total — some were healthy volunteers and some had been diagnosed with TB. Participants were split into groups and given different doses of ESAT6-CFP10 (1, 5, 10, or 20 micrograms per millilitre) by injection into the skin, alongside either a comparison TB skin-test substance or a placebo (an inactive substance). The trial was looking at how the skin reacted at the injection site, and also measured a substance in the blood called IFN-γ (a marker the immune system produces) before and after the injection. The reported data shows that for the primary outcome — checking whether healthy participants showed no skin reaction (such as swelling, redness, blistering, or inflamed lymph vessels) 24 hours after injection — most healthy participants in each dose group showed no reaction: 13 out of 14 in the 1 µg/ml group, 13 out of 14 in the 5 µg/ml group, 14 out of 14 in the 10 µg/ml group, and 13 out of 14 in the 20 µg/ml group. For the blood marker IFN-γ, the reported data shows that most healthy participants tested negative both before injection and at 72 hours after injection across all dose groups (ranging from 12 to 13 out of 14). Among TB participants, the reported numbers who tested positive for IFN-γ ranged from 17 to 19 out of the participants measured, both before and at 72 hours after injection. Regarding adverse events (unwanted health changes that were monitored), the number of participants recorded as having adverse events ranged from 14 to 19 across the four dose groups, though the data does not break this down further by type or severity. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00804713 · results posted 15 October 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,978 participants, and all of them completed the study. The trial was measuring and comparing four different tests used to detect latent tuberculosis infection (TB that is present in the body but not causing active illness). The four tests were: the tuberculin skin test (TST, a traditional skin-prick test), the QFT-GIT blood test, the T-Spot blood test, and the Battey skin test. Participants also completed a questionnaire about their personal risk factors for TB exposure. The reported data shows the following results across the participants for whom all four tests gave valid readings (1,781 to 1,803 people, depending on the measure). For the TST, when results were grouped by risk level using standard US health authority (CDC) guidelines, 2 participants in the highest-risk group, 37 in the moderate-risk group, and 20 in the lower-risk group returned a positive result. For the QFT-GIT blood test, 36 out of 1,781 participants returned a positive result, with 1,745 returning a negative result. For the T-Spot blood test, 34 participants returned a positive result and 1,747 a negative result. The Battey skin test — which uses a different threshold to define a positive result — returned a notably higher number of positives: 203 participants, compared to 1,578 who were negative. When the TST was looked at across the same group of 1,781 participants used for the other three tests, 48 returned a positive result and 1,733 a negative result. It is worth noting that the reported data explains the difference in participant numbers between the full group (1,978) and the comparison group (1,781) was because only those with valid readings across all four tests — and no borderline T-Spot results — were included in the side-by-side comparison. Any missing details beyond what is described here were not reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01363765 · results posted 12 March 2014

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of people being tested for tuberculosis (TB) using different methods. Around 18,300 people were tested using the Xpert MTB/Rif machine (a molecular test that detects TB bacteria and drug resistance), and around 16,400 people were tested using the traditional sputum smear method (examining a mucus sample under a microscope). The trial was measuring how many TB cases were officially recorded per 100,000 people per year under each testing approach, as well as the cost of finding each case. The reported data shows that in the Xpert MTB/Rif group, the rate of bacteriologically confirmed TB cases recorded was 48.7 per 100,000 people per year, compared with 30.5 per 100,000 people per year in the sputum smear group. On costs, the reported data shows the estimated cost per detected case was approximately US$715 with Xpert MTB/Rif and approximately US$799 with sputum smear testing. For secondary measures, the trial also looked at TB cases that were recorded without any laboratory test backing them up — the reported rates were 35.8 (Xpert group) versus 36.9 (smear group) per 100,000 per year. For cases where a laboratory test was done but came back negative yet the person was still recorded as having TB, the reported rates were 7.3 (Xpert group) versus 12.1 (smear group) per 100,000 per year. It is worth noting that a sizeable number of participants in both groups did not complete the study — around 5,800 in the Xpert group and 4,700 in the smear group — though the reasons for this were not detailed in the data provided here. These figures are simply what was recorded and submitted to the trial registry, and no conclusions about which approach is better or safer should be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01137370 · results posted 24 February 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 203 people in total — 116 who had tuberculosis (TB) and 87 who did not have TB. The study was measuring vitamin D levels in both groups, specifically looking at how common vitamin D deficiency was and what the typical vitamin D level (measured as a substance called 25-OHD in the blood) was among participants. The reported data shows that, among the 116 people with TB, 36.2% were found to have vitamin D deficiency. In the 87 people without TB, 27.3% were found to have vitamin D deficiency. These percentages simply reflect how many people in each group had low vitamin D levels at the time of measurement. The trial also intended to report the median (middle-point) vitamin D blood level for participants, however the reported data shows that these figures were not provided in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00953927 · results posted 12 December 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,399 infants in the investigational vaccine group (a vaccine called MVA85A/AERAS-485) and 1,398 infants in a control group. All participants had previously received the BCG vaccine and were HIV-negative. The trial set out to measure three main things: the safety profile of the investigational vaccine (by tracking side effects and serious medical events), whether the vaccine was associated with lower rates of tuberculosis (TB) diagnosis compared to the control group, and how the vaccine affected certain immune system responses in the blood. The reported data shows that in the primary outcome — tracking adverse events (unwanted health occurrences) in the 28 days after vaccination — 95.9% of infants in the investigational vaccine group had at least one adverse event recorded, compared to 83.7% in the control group. For the TB diagnosis outcome, 32 participants in the investigational vaccine group and 39 in the control group received a TB diagnosis during the study. For the immune response measurements, the reported data shows the investigational vaccine group had higher levels of certain immune cell activity compared to controls — for example, one blood test (ELISPOT, which counts specific immune cells responding to the vaccine target) recorded a median of 143 units per million blood cells in the vaccine group versus 1 unit in the control group. Regarding whether any immune response could be used to predict TB protection, the reported data notes this analysis was not completed because, as stated in the submission, the study did not show TB protection in the investigational vaccine recipients. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00449644 · results posted 25 June 2013

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called TMC207 (added to a standard background antibiotic regimen, referred to as "BR") against a placebo (a dummy treatment also added to the same background regimen) in people with a form of tuberculosis that is difficult to treat with standard medicines. The trial ran in two stages: Stage 1 involved 23 people in the TMC207 group and 24 in the placebo group, while Stage 2 involved 79 people in the TMC207 group and 81 in the placebo group. The main thing being measured was how long it took for a participant's sputum (mucus coughed up from the lungs) to test negative for the tuberculosis bacteria on two separate occasions — a result called "culture conversion." The reported data shows that in Stage 1, the TMC207 group reached that negative-test milestone in a reported median (middle value) of 51 days, while a comparable figure for the placebo group at the same 8-week check was not reported. By 24 weeks in Stage 1, the reported figures were 70 days for the TMC207 group and 126 days for the placebo group. In Stage 2, the primary measure at 24 weeks showed 83 days for the TMC207 group and 125 days for the placebo group; at the 72-week follow-up, those figures were reported as 86 days and 168 days respectively. The reported data also shows the percentage of participants whose sputum converted to negative at various points. In Stage 1, at the earliest check, approximately 47.6% of the TMC207 group and 8.7% of the placebo group had converted; by the final Stage 1 check, those figures were around 52.4% and 43.5% respectively. In Stage 2, conversion rates were reported as approximately 78.8% (TMC207) versus 57.6% (placebo) at one time point, and 62.1% versus 43.9% at the last reported Stage 2 time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00910871 · results posted 16 May 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT00910871) enrolled 233 participants, all of whom received the study drug TMC207. The trial was measuring how long it took for people with multi-drug resistant tuberculosis (MDR-TB) to reach "sputum culture conversion" — meaning that two consecutive mucus samples, taken at least 25 days apart, no longer showed signs of the MDR-TB bacteria. Of the 233 who started, 179 completed the study and 54 did not. The reported data shows that the primary outcome — the midpoint time (meaning half of participants reached this point sooner, and half took longer) for sputum culture conversion — was 57 days. For the secondary outcome, the reported data shows that 72.2% of participants were recorded as having achieved sputum culture conversion by the 24-week mark. It is worth noting that participants who left the study early or who passed away during the trial were counted as not having converted in these figures. The reported data does not include a comparison group, so these numbers reflect the TMC207 group only. Any figures beyond what is described above were not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01048697 · results posted 24 January 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 18 participants, all of whom completed the study with no dropouts. The trial involved a single group of participants who received the antibiotic ethambutol (a medicine commonly used to treat tuberculosis). The study was measuring how the body processes and clears ethambutol — in other words, how quickly the body removes the drug after it is taken. The reported data shows one primary outcome was measured: the total clearance of ethambutol from the body. Clearance, in simple terms, refers to the rate at which the drug is removed from the bloodstream by the body. The reported figure for total clearance was 80.8 litres per hour. No other outcome measures were included in the submitted results data, so no additional findings can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01311505 · results posted 30 July 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants in total, split into two groups. One group took a tuberculosis medicine called Myrin 2 first, then switched to a medicine called Rimactane; the other group took Rimactane first, then switched to Myrin 2. There was a break of at least seven days between the two treatments. The trial was comparing how the body absorbs and processes the active ingredient rifampicin from each of these two formulations — this type of study is known as a bioequivalence study, meaning it checks whether two versions of a medicine behave similarly in the body. Twenty participants completed the full trial; one person did not complete the first treatment period. The reported data shows that the two main measurements used to compare the medicines were: (1) the total amount of the drug that entered the bloodstream over time (called AUC, or "area under the curve"), and (2) the highest level of the drug measured in the blood (called Cmax, or peak concentration). For total drug exposure up to the last measurable point, Myrin 2 recorded 38.59 and Rimactane recorded 38.81 (in units of micrograms per millilitre multiplied by hours). For peak blood concentration, Myrin 2 recorded 7.89 and Rimactane recorded 8.02 (micrograms per millilitre). The reported data also shows results for several secondary measurements. The time it took to reach the peak blood level was 2.0 hours for Myrin 2 and 1.0 hour for Rimactane. The total estimated drug exposure including a projected tail period was 47.72 for Myrin 2 and 47.15 for Rimactane (same units as above). The time for the drug level in the blood to fall by half was approximately 4.1 hours for Myrin 2 and 3.9 hours for Rimactane. The estimated portion of drug exposure that was projected rather than directly measured was about 18.84% for Myrin 2 and 17.53% for Rimactane. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00468104 · results posted 24 April 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people in total — 54 were assigned to receive the drug alteplase first (followed by a dummy treatment if needed), and 46 were assigned to receive the dummy treatment first (followed by alteplase if needed). The trial was looking at whether alteplase, a drug that can break down clots and thickened fluid, could clear up fluid or infection around the lungs (pleural effusion or empyema) and related pneumonia without the person needing surgery. Scans and chest X-rays were used to check for improvement after three days of treatment. The reported data shows that the main thing being measured was how many participants avoided surgery altogether. According to the results reported on ClinicalTrials.gov, 66 out of the participants who received alteplase (at any point in the trial) did not require surgical intervention, compared to 6 out of those who received only the dummy treatment. It is worth noting that because this was a "crossover"-style design — where some people switched from one treatment to the other — the numbers across the two phases overlap, so direct comparison requires care in interpretation. For the four secondary outcomes — which looked at changes in pneumonia, fluid around the lungs, breathlessness, and signs of infection (sepsis) over six weeks — the reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of these measures, so those figures are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00096681 · results posted 17 February 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 762 participants from the community, and all 762 completed the study with none dropping out. The trial was a single-visit study that aimed to measure how common two conditions — pulmonary tuberculosis (TB, a lung infection) and HIV — were among people in the community. Participants provided a sputum (mucus coughed up from the lungs) sample to check for TB, and an oral swab sample to check for HIV. The reported data shows that out of the 762 participants, 23 had microbiologically confirmed pulmonary TB — meaning TB was detected in their sputum sample through laboratory testing. For HIV, the reported data shows that 174 out of 762 participants returned a positive result from their oral swab test. These figures represent the counts of people who tested positive at that single study visit; the trial was designed to measure how widespread these conditions were in the community at a point in time, rather than to test a treatment or intervention. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00128206 · results posted 6 December 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 364 people in total — 184 in a group taking a medicine called isoniazid and 180 in a group taking a medicine called rifampin. The trial was looking at two main things: how many people in each group had to stop taking their study medicine (because of concerning liver test results or other clinical signs picked up by their doctor), and how many people in each group managed to finish the full course of treatment. The reported data shows that when it came to stopping the study medicine early for medical reasons, 6 people in the isoniazid group and 3 people in the rifampin group reached that point. Regarding finishing the full course of treatment, 47 out of 184 people in the isoniazid group completed therapy, compared with 60 out of 180 people in the rifampin group. It is worth noting that a large number of participants did not complete the study in both groups — 137 in the isoniazid group and 120 in the rifampin group — though the reasons for this are not detailed in the reported data. The trial also listed "cost effectiveness" as something it planned to measure, but the reported data shows no figures were submitted for that outcome, so those results are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00396084 · results posted 25 June 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total, split across six treatment groups of 10 each — except the isoniazid (INH) group, which had 20 participants. The trial was measuring how quickly different antibiotics reduced the amount of tuberculosis bacteria in participants' sputum (phlegm) over the first week of treatment. The drugs being compared were three fluoroquinolone antibiotics (gatifloxacin, levofloxacin, and moxifloxacin), two dosing schedules of linezolid, and isoniazid, which is a standard tuberculosis drug used here as a reference point. Most participants completed the study — one person each in the linezolid twice-daily, moxifloxacin, and two in the isoniazid groups did not finish. The reported data shows three main measurements of bacterial load in sputum. First, an "adjusted area under the curve" (a measure of how much bacteria remained over the full study period, where a lower percentage means more bacteria were cleared) showed values between roughly 87% and 98% across the groups at various time points, with isoniazid tending to show slightly lower values than the fluoroquinolones. Second, for the first two days of treatment, the rate of fall in bacteria was reported as 0.35 for gatifloxacin, 0.45 for levofloxacin, 0.33 for moxifloxacin, and 0.67 for isoniazid (in log10 units per day). Third, between days 2 and 7, the reported rates of fall were 0.17 for gatifloxacin, 0.18 for levofloxacin, 0.17 for moxifloxacin, and 0.08 for isoniazid. The reported data also shows the peak blood concentration of each drug: levofloxacin reached the highest level at 15.6 micrograms per millilitre, followed by moxifloxacin at 6.1, gatifloxacin at 4.8, and isoniazid at 3.6. Results for two secondary outcomes — sputum mRNA clearance and sputum cytokine proteins — were listed as pending and were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00546273 · results posted 25 March 2009

  According to the results reported on ClinicalTrials.gov, this trial tested a candidate tuberculosis vaccine called RUTI in a small group of healthy volunteers. The study was structured in four separate stages, with participants in each stage receiving either one of four different doses of the vaccine (5, 25, 100, or 200 micrograms) or a placebo (an inactive injection used for comparison). In total, 24 people took part — four volunteers in each of the four vaccine-dose groups, and two placebo participants in each stage. The trial was primarily looking at how the injections were tolerated, including any pain at the injection site, and whether any notable changes showed up in blood and laboratory tests. The reported data shows that for the outcome measuring clinically notable abnormalities in blood and laboratory tests — as judged by the treating doctors — the number recorded was zero across all five groups (all four vaccine doses and the placebo group). For the other two primary outcomes — a pain score measuring each volunteer's self-reported discomfort at the injection site, and a record of any local or wider-body reactions linked to vaccination — no numerical results were included in the data submitted to ClinicalTrials.gov, so those figures cannot be described here. Similarly, the secondary outcome measuring the body's immune response to the different vaccine doses was listed but no numerical results were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.