drugset / Trial / NCT07227779
B-PaLMZ for TB Meningitis
Phase 2
Recruiting
312 enrolled
David Boulware
Brighton & Sussex Medical School · collabInfectious Diseases Institute, Uganda · collabMbarara University of Science and Technology · collabMeningitis Foundation · collabRadboud University Medical Center · collabUniversity of Minnesota · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This two-stage study will compare consented research participants with tuberculous meningitis receiving experimental Bedaquiline (B), Pretomanid (Pa), Linezolid (L); Moxifloxacin (M), Pyrazinamide (Z) known as (BPaLMZ) to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE. The experimental regimen is known as 1BPaLMZ/5PaM.
Timeline
- Start
- 2026-07-28
- Primary completion
- 2028-03-31
- Completion
- 2030-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bedaquiline | Small molecule | — | — |
| Subject | Linezolid | Other / unclassified | — | — |
| Subject | Moxifloxacin | Small molecule | — | — |
| Subject | Pretomanid | Small molecule | — | — |
| Subject | Pyrazinamide | Small molecule | — | — |