Loading clinical trials...

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

TERMINATEDPHASE3

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

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)

NCT05178862•Scynexis, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion 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).

Exclusion Criteria

•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,
+6 more criteria

Locations (101)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

Banner University Medical Center-Tucson

Tucson, Arizona, United States

UC Davis Medical Center

Sacramento, California, United States

UCSF School of Medicine

San Francisco, California, United States

University of Colorado Anschutz Medical Campus

Denver, Colorado, United States

Augusta University Medical Center

Augusta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

LSU Health Sciences Center

Shreveport, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Key Dates

Start Date

August 3, 2022

Primary Completion Date

November 7, 2025

Completion Date

December 16, 2025

Last Updated

December 19, 2025

Enrollment

ACTUAL participants

Conditions

Candidiasis, InvasiveCandidemia

Interventions

SCY-078

DRUG

Fluconazole

DRUG

Echinocandin

DRUG

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

NCT05421858

CandidemiaCandidiasis, Invasive

View study

COMPLETEDPHASE3

Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

NCT03363841

Candidiasis, InvasiveCandidemia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

Echinocandins Versus Azoles for Candidemia Treatment

Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)

A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects