A PHASE 2 NOVEL ANTIMICROBIAL COMBINATION THERAPY TO TREAT TUBERCULOUS MENINGITIS
University of Minnesota
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Presence of jaundice, known liver cirrhosis, elevated ALT or AST \>3x ULN, or total bilirubin \>2x ULN * Estimated Glomerular Filtration Rate \<3…
Interventions
- DrugBPaLMZ Regimen
bedaquiline, pretomanid, linezolid, moxifloxacin, and pyrazinamide
Locations (2)
- University of MinnesotaMinneapolis, Minnesota
- Infectious Diseases InstituteKampala