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Recruiting NCT07227779

B-PaLMZ for TB Meningitis

Phase II Interventional Tuberculous Meningitis HIV Meningitis TB - Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BPaLMZ Regimen.
Who it may be relevant to
Registry conditions: Tuberculous Meningitis, HIV, Meningitis, TB - Tuberculosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS

Overview

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.

Interventions

  • Drug BPaLMZ Regimen
    bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide

Primary outcome measures

  • Time to Death [Time frame: 24 Weeks]
  • Hierarchical composite endpoint (survival + functional status) [Time frame: 24 Weeks]
Secondary outcome measures (12)
  • Serious adverse events (SAE) [Time frame: 28 weeks]
  • Clinical Adverse Events [Time frame: 28 weeks]
  • Laboratory abnormalities [Time frame: 28 weeks]
  • Neuropathy [Time frame: 28 weeks]
  • Drug induced liver injury [Time frame: 28 weeks]
  • Change in CSF inflammatory markers [Time frame: 14 days]
  • Modified Rankin Scale [Time frame: 24 weeks]
  • Change in blood inflammatory markers [Time frame: 7 days]
  • Quantitative neurocognitive performance Z-score [Time frame: 24 weeks]
  • Change in PCR cycle threshold (Ct) value in CSF [Time frame: 14 days]
  • Altered Mental Status over time [Time frame: 10 days]
  • Additional corticosteroids use [Time frame: 24 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Uganda · 2 centers
  • Infectious Diseases Institute — Kampala
  • Mbarara University of Science and Technology — Mbarara

Identifiers

NCT: NCT07227779 · STUDY00024610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗