B-PaLMZ for TB Meningitis

A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS

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.

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