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:

• Adults between 18 and 65 years of age.
• People who are willing and able to give signed written consent, or witnessed spoken consent with a thumbprint if they cannot read or write, before any trial procedures begin.
• People whose body weight (measured in light clothing without shoes) is between 30 and 90 kg.
• People whose TB test (Xpert TB/RIF or Ultra) showed tuberculosis that is not resistant to rifampicin, with the result later confirmed by a laboratory culture.
• People whose chest X-ray shows moderate or far advanced tuberculosis in the lungs.
• People whose lung function test (FEV1) result is 65% or less of what would normally be expected for their age, height, sex, and race.
• Women who could become pregnant and are sexually active must be willing to use a contraceptive method for the entire time they are taking part in the study.
• People who do not have HIV, or if they do have HIV, their immune cell count (CD4) is at least 100 cells per microlitre and they are either already receiving HIV treatment or willing to start HIV treatment during the study.

Who may not be able to join:

• People with any condition that, in the doctor's judgment, could put their health at risk or interfere with the study assessments — for example, a collapsed lung or a significant build-up of fluid around the lungs.
• People who are pregnant or breastfeeding.
• People who are critically ill and, in the doctor's judgment, have a condition likely to result in death during the trial or follow-up period.
• People who have TB affecting the brain (TB meningitis) or other severe forms of TB that the doctor considers to carry a high risk of a poor outcome.
• People with a known allergy or sensitivity to any of the trial medicines or related substances, including rifampicin.
• People who have taken part in another clinical trial with an experimental medicine within the 8 weeks before this trial starts, or who are currently enrolled in another experimental trial.
• People who have already received more than 5 days of treatment for their current TB illness, or who received any TB treatment in the 6 months before joining (confirm with trial site).
• People with chest pain (angina) that requires treatment with nitroglycerin or similar medicines.
• People with a heart rhythm problem that requires medication, or any significant abnormality on a heart trace (ECG), as determined by the doctor.
• People whose random blood sugar level is above 140 mg/dL (or 7.8 mmol/L), or who have a history of unstable diabetes that required a hospital admission for dangerously high or low blood sugar in the past year.
• People who have used steroid medicines (taken by mouth or injection) in the past 28 days, or who are likely to need steroid medicines for another condition during the study.
• People who need to take medicines that do not work safely alongside rifampicin, such as certain HIV medicines called protease inhibitors.
• People whose blood test results show any of the following: kidney function too low, haemoglobin (red blood cell level) below 8 g/dL, platelet count too low, potassium level too low, liver enzyme levels too high (AST, alkaline phosphatase, or bilirubin outside acceptable ranges), or a positive result for hepatitis B surface antigen.

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