Interventional Recruiting Phase 2
NCT07227779 on ClinicalTrials.gov
BPaLMZ for TB Meningitis
Official title: A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
- Sponsor: David Boulware
- Collaborators: Infectious Diseases Institute, Uganda, University of Minnesota, Brighton & Sussex Medical School, Mbarara University of Science and Technology, Radboud University Medical Center, Meningitis Foundation
- Enrollment: 312 (Estimated)
- Study start: 2026-07-28 (Actual)
- Primary completion: 2028-03-31 (Estimated)
- Study completion: 2030-09-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Phase 2a consists of n = 40 single arm BPaLMZ participants. Phase 2b consists of n = 272 randomized participants.
- Masking: Single (Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief 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.
Conditions
- Tuberculous Meningitis
- HIV
- Meningitis
- TB - Tuberculosis
Intervention / Treatment
- Drug: BPaLMZ Regimen
Primary Outcome Measures
-
24-week Survival
(24 Weeks)
Survival Time -
Hierarchical composite endpoint (survival time + functional status)
(24 Weeks)
Hierarchical composite endpoint of survival time and Rankin score (0-5 scale) assessed by Win Ratio
Countries
Uganda
Locations and Investigators
-
Infectious Diseases Institute, Kampala, Uganda (Recruiting)
- Suzan Namombwe, MBChB
- David B Meya, MBChB, MMed, PhD (Principal Investigator)
-
Mbarara University of Science and Technology, Mbarara, Uganda (Recruiting)
- Conrad Muzoora, MBChB MMed
Study Officials
- David Boulware, MD (Principal Investigator) — University of Minnesota