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)
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)
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis including candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.
Key Inclusion Criteria:
Key Exclusion Criteria:
Subject has any of the following forms of invasive candidiasis at Screening:
Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).
Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
Baseline QTcF ≥ 500 msec.
Plovdiv, Bulgaria
Sofia, Bulgaria
Stara Zagora, Bulgaria
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang, China