Status:
COMPLETED
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Lead Sponsor:
Scynexis, Inc.
Conditions:
Candidiasis, Invasive
Candidemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 yea...
Eligibility Criteria
Inclusion
- Subject must fulfill the following KEY criteria to be eligible for study admission:
- Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed.
- Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days.
- Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.
Exclusion
- KEY exclusion criteria:
- Subject has a fungal disease with central nervous system involvement.
- Subject has a fungal disease of the bone and/or joint that is expected to require \>90 days of study drug treatment.
- Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
- Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
- Subject has abnormal liver test parameters: AST or ALT \>10 x ULN, and/or total bilirubin \>5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded.
- Subject has an Apache score \>16.
- Subject has serum creatinine \>3 times from Baseline (Screening/Treatment Day 1) value.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03363841
Start Date
November 15 2017
End Date
May 24 2023
Last Update
July 3 2024
Active Locations (12)
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1
Scynexis, Inc.
Jersey City, New Jersey, United States, 07302
2
St John's Medical College and Hospital
Bangalore, Karnataka, India, 560034
3
Amrita Institute of Medical Sciences (AIMS)
Kanayannur, Kochi, India, 682041
4
Institute of Critical Care Medicine Max Super Specialty Hospital
Sāket, New Delhi, India, 110017