NCT02244606

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

Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mycoses
• Candidiasis, Invasive
• Candidemia

Interventions

Type	Name	Description
DRUG	SCY-078
DRUG	Fluconazole
DRUG	Micafungin

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2014-09-19
• Last updated: 2024-06-25
• Results posted: 2024-06-25

Locations

30 sites across 5 countries: United States, El Salvador, Germany, Guatemala, Honduras