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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scynexis, Inc.
• Treatments: Echinocandins; Fluconazole; Ibrexafungerp; Micafungin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.