Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Completed · Phase 2

Conditions studied: Mycoses, Candidiasis, Invasive, Candidemia

In brief

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Key facts

Study ID

NCT02244606

Run by

Scynexis, Inc.

People needed

27

Starts

2014-09-01

Expected to finish

2016-08-01

Last updated by the study team

2024-06-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
• Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.

You may not qualify if…

• Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
• Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
• Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
• Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• University of Miami — Miami, Florida, United States
• Georgia Regents University — Augusta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mercury Street Medical Group — Butte, Montana, United States
• Albany Medical Center — Albany, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• Parkland Hospital — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• South Texas Veterans Healthcare System — San Antonio, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• University of Utah Hospitals and Clinics — Salt Lake City, Utah, United States
• Hospital Militar Central — San Salvador, El Salvador

Full record on ClinicalTrials.gov

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