To evaluate the efficacy, safety and tolerability at 8 weeks (2-months), 52 weeks (12-months), and 104 Weeks (24-months) post the start of the following treatment regimens in participants with: Drug Sensitive TB (DS-TB) patients given BPaMZ for 17 Weeks ( or 4 months) vs. Standard HRZE/HR treatment given for 26 weeks (or 6 months) and Drug Resistant TB (DR-TB) patients given BPaMZ for 26 Weeks (or 6 months)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sputum positive for tubercule bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease \[IUATLD\]/WHO scale (Appendix 1) on smear microscopy) at the trial laboratory.
* Participants with one of the following pulmonary TB conditions:
DS-TB treatment arm participants should be:
* sensitive to rifampicin and isoniazid by rapid sputum based test AND
* either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB.
DR-TB treatment arm participants should be Resistant to rifampicin and/or isoniazid.
* Of non-childbearing potential or willing to practice effective methods of birth control
* Body weight (in light clothing and no shoes) ≥ 30 kg.
* Completed informed consent form
Exclusion Criteria:
* Karnofsky score \<60%
* Any risk factor for QT prolongation
* Any planned contraindicated medicines
* Resistant to fluoroquinolones (rapid, sputum-based molecular screening tests).
Any of the following lab toxicities/abnormalities:
* CD4+ count \< 100 cells/µL (HIV infected participants)
* platelets \<75,000/mm³
* creatinine \>1.5 times upper limit of normal (ULN)
* eGFR ≤ 60 mL/min
* haemoglobin \<8.0 g/dL
* serum potassium less than the lower limit of normal for the laboratory.
* GGT: greater than 3 x ULN
* AST: ≥3.0 x ULN to be excluded;
* ALT: ≥3.0 x ULN to be excluded
* ALP: ≥3.0 x ULN to be excluded
* Total bilirubin: \>1.5 x ULN to be excluded;
* Direct bili…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Culture Negative Status by 8 Weeks