BPaLMZ for TB Meningitis
Key facts
- Where
- Kampala and Mbarara, UgandaSee the 2 sites
- Phase
- Phase 2
Where in Uganda
- Infectious Diseases InstituteKampala, UgandaTaking people
- Mbarara University of Science and TechnologyMbarara, UgandaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- David Boulware
- Trial code
- NCT07227779
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
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.
Inclusion: First Episode definite or probable TBM with physician intent to treat; Age ≥18 years; Provision of Informed Consent by participant or surrogate; Living with HIV; Weight > 35kg, estimate or measured.
Exclusion: More than 5 doses of any TB therapy received within the previous 14 days; Additional active and confirmed CNS infection; Allergy or contraindication to a study medicine; Condition which makes participation not in the participant's best interest; Presence of jaundice, known liver cirrhosis, elevated ALT or AST >3x ULN, or total bilirubin >2x ULN; Significant cardiac comorbidity, heart failure, arrhythmia, or QTc >450 ms; Known rifampicin-resistant TB; Estimated Glomerular Filtration Rate <30 ml/min/1.73m2; Pregnancy or Breastfeeding; Cryptococcal antigen positivity in blood.