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| ID | Type | Description | Link |
|---|---|---|---|
| CTA 0217 | Other Identifier | Uganda National Drug Authority (NDA) |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAT2203 Induction / MAT2203 Consolidation | Experimental | 2 days IV Amphotericin B (AMB) + flucytosine (5FC) followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by MAT2203 +fluconazole for 4 weeks of consolidation therapy |
|
| MAT2203 Induction / SOC Consolidation | Experimental | 2 days IV AMB + 5FC followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by 4 weeks of standard of care consolidation therapy |
|
| SOC Induction / SOC Consolidation | Active Comparator | Standard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAT2203 | Drug | oral lipid nanocrystal amphotericin B |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival | All-cause mortality | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Meningitis-free survival | Survival time without Cryptococcus culture-positive relapse of meningitis | 10 weeks |
| Evidence of fungicidal activity | Rate of CSF Cryptococcus clearance (early fungicidal activity [EFA]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Theresa Matkovits, PhD | Contact | 908-505-0975 | tmatkovits@matinasbiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| David R Boulware, MD | University of Minnesota | Principal Investigator |
| David B Meya, MBChB | Infectious Diseases Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Amphotericin B | Drug | Intravenous Amphotericin B |
|
| 2 weeks |
| CSF culture sterility | cumulative incidence of CSF culture sterilization | 10 weeks |
| D007239 | Infections |
| D003453 | Cryptococcosis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |