B-PaLMZ for TB Meningitis

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07227779
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Tuberculous Meningitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BPaLMZ Regimen — DRUG
    bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BPaLMZ Regimen
    bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)
  • No Intervention: Standard of Care Regimen
    rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy

Primary Outcome Measure

Time to Death [ Time Frame: 24 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
David Boulware, MD
[email protected]
612-624-9996

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By research site
University of Minnesota· Minneapolis, MN