Phase 3
N=455
Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
Tuberculosis, Pulmonary · Tuberculosis, Multidrug-Resistant · Tuberculosis, MDR · Tuberculosis · Drug-Resistant Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT03338621 ↗Enrolled (actual)
455
Serious AEs
8.9%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With Culture Negative Status by 8 Weeks — 70; 122 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pretomanid (Drug); Bedaquiline (Drug); Moxifloxacin (Drug); Pyrazinamide (Drug); HRZE (Drug); HR (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Global Alliance for TB Drug Development
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Culture Negative Status by 8 Weeks |
70; 122 | <0.001 sig |
| SECONDARY Number of Participants With Bacteriologic Failure or Relapse or Clinical Failure (Unfavorables) at 52 Weeks From Start of Therapy (12 Months) |
120; 134; 111; 24; 10; 22 | — |
| SECONDARY Time to Culture Negative Status |
6; 11; 5 | — |
Summary
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)
Eligibility Criteria
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 1.5 times upper limit of normal (ULN)
- eGFR ≤ 60 mL/min
- haemoglobin 1.5 x ULN to be excluded;
- Direct bilirubin: greater than 1x ULN to be excluded
Data sourced from ClinicalTrials.gov (NCT03338621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.