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Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

NCT03667690•Cidara Therapeutics Inc.

View on ClinicalTrials.gov

Summary

The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).

Detailed Description

A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for Injection versus an active comparator regimen of caspofungin followed by optional oral fluconazole step-down therapy in subjects with candidemia and/or invasive candidiasis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on his/her behalf.
•2. Males or females ≥18 years of age.
•3. Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤4 days (96 hours) before randomization defined as
•* ≥1 blood culture positive for yeast or Candida OR
•* Positive test for Candida from a Sponsor-approved rapid in vitro diagnostic (IVD) OR
•* Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
•4. Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤12 hours prior to the qualifying positive culture through time of randomization.
•5. Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
•6. Female subjects of childbearing potential (all female subjects between 18 years \<2 years post-menopausal unless surgically sterile) must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter (and at least 120 days from the last dose of study drug).
•7. For Candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.

Exclusion Criteria

•1. Any of the following forms of invasive candidiasis at baseline:
•1. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
•2. Osteomyelitis
•3. Endocarditis or myocarditis
•4. Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
•5. Chronic disseminated candidiasis
•6. Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract
•2. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for \>48 hours (e.g., \>2 doses of a once daily antifungal agent or \>4 doses of a twice daily antifungal agent) ≤4 days (96 hours) before randomization
•a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
•3. Alanine aminotransferase or aspartate aminotransferase levels \>10-fold the upper limit of normal
+11 more criteria

Locations (132)

University of Alabama

Birmingham, Alabama, United States

UC Davis

Sacramento, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Johns Hopkins

Baltimore, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Hospital-Rochester

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University St. Louis

St Louis, Missouri, United States

Key Dates

Start Date

October 7, 2018

Primary Completion Date

October 7, 2021

Completion Date

October 7, 2021

Last Updated

January 6, 2023

Enrollment

199

ACTUAL participants

Conditions

CandidemiaMycosesFungal InfectionInvasive Candidiases

Interventions

Rezafungin for Injection

DRUG

Caspofungin

DRUG

Fluconazole

DRUG

intravenous placebo

DRUG

oral placebo

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

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Pharmacogenomics for Better Treatment of Fungal Infections in Cancer

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Fungal InfectionHaematological Malignancy+2 more

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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: January 6, 2023Data 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.

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

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.

Pharmacogenomics for Better Treatment of Fungal Infections in Cancer

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Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Breath Analysis for the Detection of Invasive Fungal Infections

Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants