Cryptococcal Meningitis
Conditions
Brief summary
This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).
Detailed description
Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care.
Interventions
DRUGMAT2203
oral lipid nanocrystal amphotericin B
DRUGAmphotericin B
Intravenous Amphotericin B
Sponsors
University of Minnesota
Matinas BioPharma Nanotechnologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 2 weeks | All-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Meningitis-free survival | 10 weeks | Survival time without Cryptococcus culture-positive relapse of meningitis |
| Evidence of fungicidal activity | 2 weeks | Rate of CSF Cryptococcus clearance (early fungicidal activity \[EFA\]) |
| CSF culture sterility | 10 weeks | cumulative incidence of CSF culture sterilization |
Contacts
Primary ContactTheresa Matkovits, PhD
Outcome results
None listed