Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
NCT ID: NCT05541107
Last Updated: 2022-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
270 participants
INTERVENTIONAL
2023-01-31
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MAT2203 Induction / MAT2203 Consolidation
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
oral lipid nanocrystal amphotericin B
MAT2203 Induction / SOC Consolidation
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
MAT2203
oral lipid nanocrystal amphotericin B
SOC Induction / SOC Consolidation
Standard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole)
Amphotericin B
Intravenous Amphotericin B
Interventions
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MAT2203
oral lipid nanocrystal amphotericin B
Amphotericin B
Intravenous Amphotericin B
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability and willingness to provide informed consent
* Willing to receive protocol-specified lumbar punctures
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Matinas BioPharma Nanotechnologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David R Boulware, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
David B Meya, MBChB
Role: PRINCIPAL_INVESTIGATOR
Infectious Diseases Institute
Central Contacts
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Other Identifiers
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CTA 0217
Identifier Type: OTHER
Identifier Source: secondary_id
MB-70018
Identifier Type: -
Identifier Source: org_study_id
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