Interventional Not yet recruiting Phase 3
NCT05541107 on ClinicalTrials.gov
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
- Sponsor: Matinas BioPharma Holdings Inc
- Collaborators: University of Minnesota
- Enrollment: 270 (Estimated)
- Study start: 2023-01-01 (Estimated)
- Primary completion: 2024-10-01 (Estimated)
- Study completion: 2025-01-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).
Conditions
- Cryptococcal Meningitis
Intervention / Treatment
- Drug: MAT2203
- Drug: Amphotericin B
Primary Outcome Measures
-
Survival
(2 weeks)
All-cause mortality
Study Officials
- David R Boulware, MD (Principal Investigator) — University of Minnesota
- David B Meya, MBChB (Principal Investigator) — Infectious Diseases Institute