Phase 2 Tuberculosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are willing to give written consent and follow all study procedures for the full duration of the trial.
• People aged between 18 and 65 years old (inclusive), of any gender.
• People who weigh between 40 and 90 kg (measured in light clothing, without shoes).
• People who have been newly diagnosed with pulmonary tuberculosis (TB affecting the lungs) and have not yet received treatment for this current episode.
• People whose TB has been confirmed by molecular testing to be sensitive (not resistant) to the antibiotics rifampicin and isoniazid.
• People who have had a chest X-ray during or up to 2 weeks before the screening period that, in the investigator's opinion, is consistent with TB.
• People whose TB test (GeneXpert) shows a medium or high level of TB bacteria.
• People who are able to produce enough sputum (phlegm), estimated at 10 ml or more from an overnight collection.
• People who are not able to become pregnant, or who are using an effective method of birth control as defined by the trial guidelines.
• Women of childbearing potential who are not already using an approved form of contraception must agree to receive injectable or another approved contraceptive method during screening and at least 1 day before the first dose of study medication.
• Male participants must agree, during the study and for at least 90 days after the last dose, to avoid donating semen and to use a condom during any sexual activity that could result in the transfer of ejaculate to another person.

Who may not be able to join:

• People who have significant health conditions other than TB that, in the investigator's opinion, could affect safety or interfere with the trial results.
• People whose general health is so poor that any delay in starting treatment would not be safe, in the investigator's opinion.
• People with a history of epilepsy, seizures, or other neurological or psychiatric conditions that could affect safety or trial results.
• People with cirrhosis or serious, unstable liver or bile duct disease, including specific signs such as fluid build-up in the abdomen, brain problems related to liver disease, bleeding disorders, low blood protein, enlarged veins in the food pipe or stomach, or ongoing jaundice (except for Gilbert's syndrome or gallstones without symptoms).
• People with a history of an underactive thyroid (hypothyroidism).
• People with an abnormal heart rhythm measurement (QTcF above 450 milliseconds) at the start of the trial.
• People who show significant signs of TB outside the lungs, as assessed by the investigator.
• People with a known allergy to any of the study medications, as confirmed by the investigator.
• People whose use of alcohol or drugs is considered by the investigator to be serious enough to affect their safety or ability to participate.
• People who are HIV positive and have a CD4 cell count below 250 cells/mm³, or who are on an HIV treatment (antiretroviral therapy, ART) regimen not permitted by the trial, or who are not on ART and are unwilling to wait until the study treatment is completed before starting ART (confirm with trial site for permitted ART regimens).
• Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial period or within at least 90 days after the last dose of study medication; male participants who are planning to father a child within at least 90 days after their last dose.
• People who have taken part in another clinical trial using an investigational drug within 8 weeks before screening.
• People who have already received any treatment for this current episode of TB, including a range of specific antibiotics used against TB bacteria.
• People who have taken immune-suppressing medications (such as TNF-alpha inhibitors) within 2 weeks before screening, or steroid tablets for more than 7 days within the 2 weeks before screening.
• People who would need to take medications during the trial that are not permitted alongside the study drugs.
• People who test positive for hepatitis B surface antigen.
• People who test positive for hepatitis C antibodies.
• People whose blood test results at screening fall outside the safety limits set by the trial, including abnormal levels of kidney function, haemoglobin (red blood cells), platelets, potassium, liver enzymes, bilirubin, white blood cells, thyroid hormone, or blood sugar (confirm specific values with trial site).

Important: Always verify eligibility with the trial site directly before applying.