B-PaLMZ for TB Meningitis

University of Minnesota (UMN)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Tuberculous Meningitis

Treatments: Drug: BPaLMZ Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT07227779

STUDY00024610

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

BPaLMZ Regimen

Experimental group

Description:

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

Treatment:

Drug: BPaLMZ Regimen

Standard of Care Regimen

No Intervention group

Description:

rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy