NCT07227779RecruitingPhase 2
BPaLMZ for TB Meningitis
A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
This two-stage study will compare consented research participants with tuberculous meningitis receiving experimental Bedaquiline (B), Pretomanid (Pa), Linezolid (L); Moxifloxacin (M), Pyrazinamide (Z) known as (BPaLMZ) to controls receiving SOC of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E), known as RHZE. The experimental regimen is known as 1BPaLMZ/5PaM.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 11 Nov 2025
- Start date
- 28 Jul 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- David Boulware
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT07227779
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 312
- From 28 Jul 2026 to the primary completion date, 31 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- More than 5 doses of any TB therapy received within the previous 14 days
Other illness
- Additional active and confirmed CNS infection
- Allergy or contraindication to a study medicine
- Condition which makes participation not in the participant's best interest
Lab values
- Presence of jaundice, known liver cirrhosis, elevated ALT or AST \>3x ULN, or total bilirubin \>2x ULN
- Significant cardiac comorbidity, heart failure, arrhythmia, or QTc \>450 ms
Other
- Known rifampicin-resistant TB
- Estimated Glomerular Filtration Rate \<30 ml/min/1.73m2
- Pregnancy or Breastfeeding
- Cryptococcal antigen positivity in blood
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Infectious Diseases Institute Coordinator of this site? Confirm its status | Kampala | Uganda | Recruiting |
| Mbarara University of Science and Technology Coordinator of this site? Confirm its status | Mbarara | Uganda | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.