Clinical Trial: Oral SCY-078 vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral SCY-078 vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis<
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 candidiasis.
Detailed Summary: 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.
Sponsor: Scynexis, Inc.
Current Primary Outcome:
- Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements [ Time Frame: from time of informed consent through 6-weeks after last study drug ]
- Dose of SCY-078 that achieves the target exposure (AUC) [ Time Frame: during randomized study drug (administered for a maximum of 23 days) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Global response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
- Clinical response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
- Microbiological response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
- Relapse [ Time Frame: 2-weeks and 6-weeks after the end of all antifungal therapy ]
Original Secondary Outcome: Same as current
Information By: Scynexis, Inc.
Dates:
Date Received: September 12, 2014
Date Started: September 2014
Date Completion:
Last Updated: September 15, 2016
Last Verified: September 2016
