B-PaLMZ for TB Meningitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Boulware
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BPaLMZ Regimen
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
David Boulware
Lead sponsor
University of Minnesota
Sponsor institution
Infectious Diseases Institute, Uganda
Collaborator
University of Minnesota
Collaborator
Brighton & Sussex Medical School
Collaborator
Mbarara University of Science and Technology
Collaborator
Radboud University Medical Center
Collaborator
Meningitis Foundation
Collaborator
Source ClinicalTrials.gov