CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

Completed · Phase 2 · Has a placebo group

Conditions studied: Candidemia, Mycoses, Fungal Infection, Fungemia, Invasive Candidiasis

In brief

The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).

Key facts

Study ID

NCT02734862

Run by

Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

207

Starts

2016-07-26

Expected to finish

2019-07-01

Last updated by the study team

2020-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or positive gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site)
• willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required. Patients receiving only medications and measures for comfort and not cure should not be enrolled.
• female subjects of child bearing potential <2 years post menopausal must agree to one barrier method and one highly effective method of birth control or sexual abstinence.
• male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.
• 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 their behalf.
• presence of one or more systemic signs attributable to candidemia and/or invasive candidiasis

You may not qualify if…

• Any of the following forms of IC:
• 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
• neutropenia
• alanine aminotransferase or aspartate aminotransferase levels >10 fold the upper limit of normal
• severe hepatic impairment in subjects with a history of chronic cirrhosis
• greater than 48 hours systemic antifungal treatment at approved doses to treat candidemia
• pregnant females
• lactating females who are nursing
• known hypersensitivity to CD101, caspofungin, any echinocandin, or to any of their excipients
• previous participation in this or any previous CD101 study
• recent use of an investigational medicinal product within 28 days of first dose of study drug or presence of an investigational device at the time of screening
• Principal Investigator considers the subject should not participate
• presence of indwelling vascular catheter or device that cannot be removed and is likely to be the source of candidemia

Where it is running

• University of California - Davis — Davis, California, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Augusta University — Augusta, Georgia, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Harper University Hospital — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mercury Street Medical — Butte, Montana, United States
• Albany Medical Center — Albany, New York, United States
• Mercy Health - St. Vincent Medical Center - ID Clinical Research — Toledo, Ohio, United States
• Reading Hospital and Medical Center — West Reading, Pennsylvania, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• Virginia Tech, Carillion School of Medicine — Roanoke, Virginia, United States
• Jules Bordet Institute — Brussels, Belgium
• CHU Brugman — Brussels, Belgium
• Erasme Hospital — Brussels, Belgium
• UCL Saint-LUC — Brussels, Belgium
• UZ Gent Algemene Inwendige Zietken — Ghent, Belgium
• University Hospital Brussels — Jette, Belgium
• University Hospital Leuven — Leuven, Belgium
• CHU Sart-Tillman — Liège, Belgium
• University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology — Sofia, Bulgaria
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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