Conditions: Mycoses Candidiasis, Invasive Candidemia
Keywords: Invasive Candidiasis Invasive Candida infections Candidemia SCY-078 Micafungin Fluconazole Echinocandin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 27
Healthy volunteers: no

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 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.

Arms:
arm 1: A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days. arm 2: A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days. arm 3: Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.

Interventions: intervention 1: SCY-078 intervention 2: Fluconazole intervention 3: Micafungin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: