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B-PaLMZ for TB Meningitis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

B-PaLMZ for TB Meningitis

A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS

NCT07227779•University of Minnesota

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (2)

University of Minnesota

Minneapolis, Minnesota, United States

Infectious Diseases Institute

Kampala, Uganda

Key Dates

Start Date

February 15, 2026

Primary Completion Date

August 31, 2030

Completion Date

August 31, 2030

Last Updated

November 13, 2025

Enrollment

240

ESTIMATED participants

Conditions

Tuberculous Meningitis

Interventions

BPaLMZ Regimen

DRUG

Contacts

David Boulware, MD

CONTACT

612-624-9996 coat.trial@gmail.com

Darlisha Williams, MPH

CONTACT

612-624-0469 will1223@umn.edu

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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B-PaLMZ for TB Meningitis

Inclusion Criteria

Exclusion Criteria

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

Intensified Short Course Regimen for TBM in Adults

Rifampicin Explorative PK Study for Tuberculous Meningitis Comparing Oral and Intravenous Preparation