NCT05178862

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

Conditions

• Candidiasis, Invasive
• Candidemia

Interventions

Type	Name	Description
DRUG	SCY-078	Oral ibrexafungerp (SCY-078) as step-down therapy.
DRUG	Fluconazole	Oral fluconazole (SCY-078) as step-down therapy.
DRUG	Echinocandin	Intravenous echinocandin

Timeline

• Start date: 2022-08-03
• Primary completion: 2025-11-07
• Completion: 2025-12-16
• First posted: 2022-01-05
• Last updated: 2025-12-19

Locations

101 sites across 13 countries: United States, Belgium, Bulgaria, Canada, China, France, Germany, Greece, Israel, Italy, South Africa, South Korea, Spain

Regulatory

• FDA-regulated drug study