This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.
This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (for a subset of subjects) of oral SCY-078 in male and female subjects ≥18 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days. Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment. Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Oral SCY-078
Scynexis, Inc.
Jersey City, New Jersey, United States
St John's Medical College and Hospital
Bangalore, Karnataka, India
Amrita Institute of Medical Sciences (AIMS)
Kanayannur, Kochi, India
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
The percentage of participants with global success at End of Treatment (EoT) as determined by the Data Monitoring Committee. Global success is defined as complete or partial resolution of signs and symptoms associated with the fungal disease and mycological eradication.
Time frame: At (EoT) Visit (up to 90 days after Day 1)
Percent of Participants With Treatment-emergent Adverse Events
Percent of participants with treatment-emergent Adverse Events (TEAEs)
Time frame: Through study completion, up to 132 days
Number of Participants Discontinued Due to Adverse Events
Number of participants with Discontinuations due to Adverse Events
Time frame: Through study completion (up to 132 Days)
Percentage of Participants With Recurrence of Baseline Fungal Infection
The percentage of participants with a recurrence of the baseline fungal infection at the 6 week follow-up
Time frame: 42 Days after the End of Treatment visit
Percentage of Participants Surviving 42 and 84 Days
Percentage of participants Surviving at Day 42 and Day 84 after Day 1 (first dose of study drug)
Time frame: Day 42 and Day 84 after first dose of study drug
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