Trial to Evaluate the Efficacy, Safety and Tolerability of BPaMZ in Drug-Sensitive (DS-TB) Adult Patients and Drug-Resistant (DR-TB) Adult Patients
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)
Timeline
- Start
- 2018-07-30
- Primary completion
- 2021-07-01
- Completion
- 2022-06-10
Outcome
Met primary endpoint
paper For DS-TB, BPaMZ successfully met the primary efficacy endpoint of sputum culture conversion. PMID 38768617 ↗
paper 122 (84%) of 145 and 70 (47%) of 148 participants were culture-negative on 4 months of BPaMZ and HRZE, respectively, with a hazard ratio for earlier negative status of 2·93 (95% CI 2·17-3·96; p<0·0001). PMID 38768617 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | 100 mg | — |
| Comparator | Ethambutol | Small molecule | 275 mg | — |
| Comparator | Isoniazid | Small molecule | 75 mg | — |
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
| Subject | Pretomanid | Small molecule | 200 mg | — |
| Subject | Pyrazinamide | Small molecule | 400 mg | — |
| Subject | Pyrazinamide | Small molecule | 1500 mg | — |
| Comparator | Rifampicin | Small molecule | 150 mg | — |