Status:
COMPLETED
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Lead Sponsor:
Scynexis, Inc.
Conditions:
Mycoses
Candidiasis, Invasive
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT02244606
Start Date
September 1 2014
End Date
August 1 2016
Last Update
June 25 2024
Active Locations (30)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
UC Davis Medical Center
Sacramento, California, United States, 95817
3
University of Colorado Denver
Aurora, Colorado, United States, 80045
4
University of Miami
Miami, Florida, United States, 33125