B-PaLMZ for TB Meningitis

Recruiting now · Phase 2

Conditions studied: Tuberculous Meningitis, HIV, Meningitis, TB - Tuberculosis

In brief

This two-stage study will compare consented research participants with tuberculous meningitis receiving BPaLMZ to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE.

Key facts

Study ID

NCT07227779

Run by

David Boulware

People needed

240

Starts

2026-07-28

Expected to finish

2030-09-30

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Infectious Diseases Institute — Kampala, Uganda (enrolling)
• Mbarara University of Science and Technology — Mbarara, Uganda (enrolling)

Full record on ClinicalTrials.gov

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