TERMINATED

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

Official Title

A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

Quick Facts

Study Start:2022-08-03

Study Completion:2025-12-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05178862

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed. * Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever \[on one occasion \> 38°C\], hypotension, or local signs of inflammation).	* Subject has any of the following forms of invasive candidiasis at Screening: * Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed), * Osteomyelitis, * Endocarditis or myocarditis, * Meningitis, endophthalmitis, or any central nervous system infection, * Chronic disseminated candidiasis, * Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract, * Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens, * Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection, * Patients who failed a previous antifungal therapy for the same infection, * Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis. * Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 10-fold the upper limit of normal (ULN). * Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score \> 9). * Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin. * Baseline QTcF ≥ 500 msec.

Inclusion Criteria

Exclusion Criteria

* Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
* Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever \[on one occasion \> 38°C\], hypotension, or local signs of inflammation).

* Subject has any of the following forms of invasive candidiasis at Screening:
* Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
* Osteomyelitis,
* Endocarditis or myocarditis,
* Meningitis, endophthalmitis, or any central nervous system infection,
* Chronic disseminated candidiasis,
* Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
* Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
* Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
* Patients who failed a previous antifungal therapy for the same infection,
* Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
* Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 10-fold the upper limit of normal (ULN).
* Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score \> 9).
* Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
* Baseline QTcF ≥ 500 msec.

Contacts and Locations

Principal Investigator

David Angulo, MD

STUDY_DIRECTOR

Scynexis, Inc.

Study Locations (Sites)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, 70121

United States

Banner University Medical Center-Tucson

Tucson, Arizona, 85719

United States

UC Davis Medical Center

Sacramento, California, 95817

United States

UCSF School of Medicine

San Francisco, California, 94143

United States

University of Colorado Anschutz Medical Campus

Denver, Colorado, 80291

United States

Augusta University Medical Center

Augusta, Georgia, 30912

United States

University of Chicago Medical Center

Chicago, Illinois, 60637

United States

Ochsner Medical Center

New Orleans, Louisiana, 70121

United States

LSU Health Sciences Center

Shreveport, Louisiana, 71103

United States

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Johns Hopkins Hospital

Baltimore, Maryland, 21287

United States

University of Michigan Hospital

Ann Arbor, Michigan, 48109

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Mercury Street Medical Group, PLLC

Butte, Montana, 59701

United States

Duke University

Durham, North Carolina, 27710

United States

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15260

United States

Rhode Island Hospital

Providence, Rhode Island, 02903

United States

The Miriam Hospital

Providence, Rhode Island, 02906

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Scynexis, Inc.

David Angulo, MD, STUDY_DIRECTOR, Scynexis, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-03

Study Completion Date2025-12-16

Study Record Updates

Study Start Date2022-08-03

Study Completion Date2025-12-16

Terms related to this study

Additional Relevant MeSH Terms

Candidiasis, Invasive
Candidemia