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B-PaLMZ for TB Meningitis

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 2 changed
See other at-risk trials from David Boulware

Record History

See every version on ClinicalTrials.gov ↗

  1. Study description expanded, about 5 words
  2. Enrollment increased: 240 → 312 participants
    • Secondary endpoints: details revised at 3 of 14 entries
    • Collaborators: details revised at 1 of 6 entries
    • Eligibility criteria expanded, about 4 words
  3. Primary endpoint(s) modifiedv6 Show 6 more changesShow less
    • Sponsor changed: University of Minnesota to David Boulware
    • Recruitment opened
    • Primary completion moved earlier from Aug 31, 2030 to Mar 31, 2028
    • Study completion pushed from Aug 31, 2030 to Sep 30, 2030
    • Study sites: 3 to 2
    • Collaborators: 5 to 6
  4. Lead sponsor: University of Minnesota to David Boulwarev5 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Study completion date: Aug 31, 2030 to Sep 30, 2030
    • Start date: Aug 10, 2026 to Jul 28, 2026
    • Secondary endpoints expanded, about 57 words
    • Collaborators: 1 to 5
  5. Start date: Jul 20, 2026 to Aug 10, 2026v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 15, 2026 to Jul 20, 2026
    • Study sites: 2 to 3
    v3
  2. Start date: Feb 15, 2026 to Jun 15, 2026v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
David Boulware
2 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07227779
Lead Sponsor David Boulware
Collaborators: Infectious Diseases Institute, Uganda, University of Minnesota, Brighton & Sussex Medical School, Mbarara University of Science and Technology, Radboud University Medical Center, Meningitis Foundation
Conditions
(from sponsor)		 Tuberculous Meningitis, HIV, Meningitis, TB - Tuberculosis
Related terms Latent Tuberculosis, Meningitis, Tuberculosis, Meningeal
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov