B-PaLMZ for TB Meningitis

September 11, 2026 updated by: David Boulware

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Infectious Diseases Institute
        • Contact:
        • Principal Investigator:
          • David B Meya, MBChB, MMed, PhD
      • Mbarara, Uganda
        • Recruiting
        • Mbarara University of Science and Technology
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Death
Time Frame: 24 Weeks
24 Weeks
Hierarchical composite endpoint (survival + functional status)
Time Frame: 24 Weeks
Hierarchical composite endpoint of survival and modified Rankin score (0-6 scale) assessed by Win Ratio
24 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serious adverse events (SAE)
Time Frame: 28 weeks
Incidience of Serious adverse events
28 weeks
Clinical Adverse Events
Time Frame: 28 weeks
Clinical Adverse Events, by grade (1-5) associated with TB drug discontinuation, dose reduction, or interruption >3 days
28 weeks
Laboratory abnormalities
Time Frame: 28 weeks
Number of participants with grade 3 or 4 abnormal laboratory values, by the Division of AIDS toxicity grading scale
28 weeks
Neuropathy
Time Frame: 28 weeks
Incidence of Neuropathy
28 weeks
Drug induced liver injury
Time Frame: 28 weeks
Drug induced liver injury with Grade >=3 with serum alanine aminotransferase (ALT) >5x upper limit or normal or total bilirubin >2.5x upper limit of normal)
28 weeks
Change in CSF inflammatory markers
Time Frame: 14 days
Change in CSF leukocytes from baseline to day 7 and 14 visits.
14 days
Modified Rankin Scale
Time Frame: 24 weeks

Modified Rankin Score as an ordinal score (0-6 scale) of:

0 Alive: no residual symptoms or disability.

  1. No significant disability: symptoms are present but do not prevent carrying out all usual duties and activities; able to carry out all pre-TBM activities.
  2. Slight disability: unable to carry out all pre-TBM activities but able to look after self without daily help.
  3. Moderate disability: requires some assistance with tasks but able to walk without assistance.
  4. Moderately severe disability: unable attend to bodily functions or walk without assistance.
  5. Severe disabilities: bedridden, incontinent, requires continuous care and attention.
  6. Dead
24 weeks
Change in blood inflammatory markers
Time Frame: 7 days
Change in white blood cell count from baseline to day 7 visit
7 days
Quantitative neurocognitive performance Z-score
Time Frame: 24 weeks
Quantitative neurocognitive performance Z-score scaled to Ugandan population adult norms where population average = 0. Performance is Z-scored such that performance that is one standard deviation better than average is +1 and one standard deviation worse is -1.
24 weeks
Change in PCR cycle threshold (Ct) value in CSF
Time Frame: 14 days
Change in PCR cycle threshold (Ct) value in CSF from baseline to Day 7 and 14 visits.
14 days
Altered Mental Status over time
Time Frame: 10 days
Number of days with Glasgow Coma Scale score = 15 within the first 10 days
10 days
Additional corticosteroids use
Time Frame: 24 weeks
Additional corticosteroids use in TBM survivors (beyond initial use)
24 weeks
Change in CSF glcuose
Time Frame: 14 days
Change in CSF glcuose from baseline to day 7 to day 14
14 days
Change in serum C-reactive protein
Time Frame: 7 days
Change in serum C-reactive protein (CRP) from baseline to day 7
7 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
David Boulware

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Radboud University Medical Center
University of Minnesota
Mbarara University of Science and Technology
Brighton & Sussex Medical School
Infectious Diseases Institute, Uganda
Meningitis Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00024610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

deidentified dataset

IPD Sharing Time Frame

At time of publication, as per ICJME

IPD Sharing Access Criteria

public access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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