Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

MB-70018

This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).

2023-01-01

2024-10-01

2025-01-01

Not yet recruiting

Early phase I

270

Inclusion Criteria: * CSF cryptococcal antigen (CrAg) positive meningitis * Ability and willingness to provide informed consent * Willing to receive protocol-specified lumbar punctures Exclusion Criteria: * Glasgow Coma Scale \< 15 at time of consent * Received \>= 3 doses of amphotericin B within prior 30 days * Inability to take enteral (oral or nasogastric) medicine * Cannot or unlikely to attend regular clinic visits * Receiving chemotherapy or corticosteroids * Suspected paradoxical immune reconstitution inflammatory syndrome (IRIS) * Pregnancy or breastfeeding * Previous administration of MAT2203 * Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 270, 'type': 'ESTIMATED'}}

2022-09-15