B-PaLMZ for TB Meningitis

Not Applicable

Not yet recruiting

• Conditions: Tuberculous Meningitis
• Interventions: Drug: BPaLMZ Regimen

• Registration Number: NCT07227779
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-11
• Study First Submitted QC: 2025-11-11
• Last Update Submitted: 2025-11-11
• Study First Posted: 2025-11-13
• Last Update Posted: 2025-11-13
• Study Start: 2026-02-15
• Primary Completion: 2030-08-31
• Study Completion: 2030-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPaLMZ Regimen	BPaLMZ Regimen	bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)

Primary Outcome Measures

Name	Time	Method
Time to Death	24 Weeks
Functional Status	24 Weeks	Modified Rankin score

Trial Locations

Locations (2)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Infectious Diseases Institute; 🇺🇬 Kampala, Uganda