RECRUITING Phase 2 ClinicalTrials.gov

BPaLMZ for TB Meningitis

Sponsor: David Boulware • ClinicalTrials.gov ID: NCT07227779

Registry updated: 2026-10-16

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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.

Interventions

BPaLMZ Regimen (Drug)
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * Additional active and confirmed CNS infection * Known rifampicin-resistant TB * Allergy or contraindication to a study medicine * More than 5 doses of any TB therapy received within the previous 14 days * Presence of jaundice, known liver cirrhosis, elevated ALT or AST \>3x ULN, or total bilirubin \>2x ULN * Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2 * Significant cardiac comorbidity, heart failure, arrhythmia, or QTc \>450 ms * Pregnancy or Breastfeeding * Cryptococcal antigen positivity in blood * Condition which makes participation not in the participant's best interest

Conditions

Tuberculous Meningitis HIV Meningitis TB - Tuberculosis

Locations

Infectious Diseases Institute — Kampala, Uganda
Mbarara University of Science and Technology — Mbarara, Uganda

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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