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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Oral ibrexafungerp (SCY-078) as step-down therapy.
Oral fluconazole (SCY-078) as step-down therapy.
Intravenous echinocandin
All-cause mortality (US FDA Only)
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Time frame: Day 30
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Time frame: Up to 6 weeks
Global Response at Day 14
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Time frame: Day 14
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