A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Uganda
Infectious Diseases Institute
RECRUITING
Kampala
Mbarara University of Science and Technology
RECRUITING
Mbarara
Contact Information
Primary
David Boulware, MD
coat.trial@gmail.com
612-624-9996
Backup
Darlisha Williams, MPH
will1223@umn.edu
612-624-0469
Time Frame
Start Date: 2026-07-28
Estimated Completion Date: 2030-09-30
Participants
Target number of participants: 240
Treatments
Experimental: BPaLMZ Regimen
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide (BPaLMZ)
No_intervention: Standard of Care Regimen
rifampicin, isoniazid, pyrazinamide, ethambutol (RHZE) therapy
Related Therapeutic Areas
Sponsors
Collaborators: Mbarara University of Science and Technology, Brighton & Sussex Medical School, Meningitis Foundation, Infectious Diseases Institute, Uganda, Radboud University Medical Center, University of Minnesota
Leads: David Boulware