Phase 2 Tuberculosis Trial, Recruiting
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- People who are suspected of having pulmonary tuberculosis (TB in the lungs) AND have had at least one sputum (mucus/phlegm) sample come back positive for TB bacteria — either through a standard smear test or through a specific lab test called Xpert MTB/RIF showing a "medium" or "high" level of bacteria, with no rifampicin resistance detected
- People who have not yet started any treatment for tuberculosis
- People aged 12 years or older
- People who have a verifiable home address that can be visited, and who are willing to let the study team know if their address changes during the study
- People who have a documented result on file showing their HIV status
- People who have a documented blood sugar level and diabetes status on file
- People who are HIV-positive and have a recent immune cell count (CD4 count) of at least 100 cells/mm³, tested within the past 30 days
- People whose recent blood test results (taken within the past 14 days) meet all of the following: liver enzyme (ALT) levels not too high, bilirubin levels not too high, kidney function (creatinine) within an acceptable range, potassium levels at or above 3.5 meq/L, haemoglobin of at least 7.0 g/dL, and a platelet count of at least 100,000/mm³
- Women who could become pregnant must have had a negative pregnancy test within the past 7 days
- People who have given written consent to participate in the study
Who may not be able to join:
- People who are currently pregnant or breastfeeding
- People who are unable to swallow or take medications by mouth
- People who are already receiving treatment for tuberculosis
- People who weigh less than 40 kg
- People who have a known allergy or bad reaction to any of the medications used in the study
- People whose TB bacteria are already known to be resistant to any of these medications: rifampin, isoniazid, pyrazinamide, or ethambutol
- People with significant other health conditions, including certain heart problems (such as heart failure, coronary heart disease, or irregular heartbeat), cancer, or other serious medical conditions
- People with a known personal or family history of bleeding disorders
- People with reduced kidney function, specifically where creatinine clearance is above 1.5 times the upper limit of the normal range (confirm with trial site)
- People with muscle inflammation (myositis) or a muscle enzyme (creatinine phosphokinase) level more than three times the upper limit of normal
- People whose overall health situation, in the opinion of the study doctor, means joining the trial would not be in their best interest
- People who, after joining the study, have sputum samples that never grow TB bacteria across three test points (this would result in removal from the study)
- People whose TB bacteria are later found to be resistant to isoniazid, rifampin, or fluoroquinolones (a class of antibiotics) — these individuals would be removed from the study after enrolment
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Olanisun O Adewole, MD, Obafemi Awolowo University /Teaching Hospital, Ile- Ife, Osun State, Nigeria
Phone: +2348034074930
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Safety: Proportion of participants with grade 3 or higher adverse events during study drug treatment; Efficacy: TB disease-free survival at six months post randomization; Efficacy:Time to stable sputum culture conversion on solid and /liquid media; Efficacy: Proportion of participants who are culture negative
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.