B-PaLMZ for TB Meningitis

April 9, 2026 updated by: University of Minnesota

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Darlisha Williams, MPH
  • Phone Number: 612-624-0469
  • Email: will1223@umn.edu

Study Locations

  • Uganda
      • Kampala, Uganda
  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BPaLMZ Regimen
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)
Drug: BPaLMZ Regimen
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide
No Intervention: Standard of Care Regimen
rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Death
Time Frame: 24 Weeks
24 Weeks
Functional Status
Time Frame: 24 Weeks
Modified Rankin score
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Infectious Diseases Institute

Investigators

  • Principal Investigator: David Boulware, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

August 31, 2030

Study Completion (Estimated)

August 31, 2030

Study Registration Dates

First Submitted

November 11, 2025

First Submitted That Met QC Criteria

November 11, 2025

First Posted (Actual)

November 13, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00024610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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