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NCT05541107 Clinical Trial

Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

Cryptococcal Meningitis Clinical Trial

— EnACT3  

Official title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05541107
Other study ID # MB-70018
Secondary ID CTA 0217
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date January 2023
Est. completion date January 2025

Study information
Verified date September 2022
Source Matinas BioPharma Nanotechnologies, Inc.
Contact Theresa Matkovits, PhD
Phone 908-505-0975
Email tmatkovits@matinasbiopharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 270
Est. completion date January 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MAT2203
oral lipid nanocrystal amphotericin B
• Amphotericin B
Intravenous Amphotericin B

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Matinas BioPharma Nanotechnologies, Inc. University of Minnesota

Outcome
Type Measure Description Time frame Safety issue
Primary Survival All-cause mortality 2 weeks
Secondary Meningitis-free survival Survival time without Cryptococcus culture-positive relapse of meningitis 10 weeks
Secondary Evidence of fungicidal activity Rate of CSF Cryptococcus clearance (early fungicidal activity [EFA]) 2 weeks
Secondary CSF culture sterility cumulative incidence of CSF culture sterilization 10 weeks
See also
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Completed NCT04031833 - Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial (EnACT) Phase 1/Phase 2
Completed NCT00830856 - Early Versus Delayed Antiretroviral Therapy (ART) in the Treatment of Cryptococcal Meningitis in Africa N/A
Completed NCT04532463 - Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal Meningitis
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Active, not recruiting NCT01715922 - Study Evaluating Efficiency and Tolerance of High-dose Fluconazole Associated With Flucytosine as Induction Therapy for Cryptococcal Meningitis Associated With HIV in Sub-saharan Africa Phase 2/Phase 3
Completed NCT00145249 - Amphotericin Alone or in Combination With Fluconazole for AIDS-Associated Meningitis Phase 2
Completed NCT01802385 - Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis Phase 3
Terminated NCT00324025 - Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS Phase 2
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Active, not recruiting NCT02624453 - Pre-Antiretroviral Therapy (ART) Cryptococcal Antigen Screening in AIDS N/A
Recruiting NCT00867269 - Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Completed NCT01535469 - Operational Research for Cryptococcal Antigen Screening Phase 4
Active, not recruiting NCT04072640 - Three Induction Treatments on Cryptococcal Meningitis Early Phase 1
Not yet recruiting NCT02686853 - Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis Phase 4
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