Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Completed · Phase 3
Conditions studied: Candidiasis, Invasive, Candidemia
In brief
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.
Key facts
- Study ID
- NCT03363841
- Run by
- Scynexis, Inc.
- People needed
- 30
- Starts
- 2017-11-15
- Expected to finish
- 2023-05-24
- Last updated by the study team
- 2024-07-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
- Institute of Critical Care Medicine Max Super Specialty Hospital — Sāket, New Delhi, India
- King George Medical University — Lucknow, Uttar Pradesh, India
- Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care — Chandigarh, India
- Aga Khan University Hospital — Karachi, Sindh, Pakistan
- Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157 — Centurion, Gauteng, South Africa
- Emmed Research, Jakarta Hospital — Pretoria, Gauteng, South Africa
- Into Research, Life Groenkloof Hospital — Pretoria, Gauteng, South Africa
- Johese Clinical Research, Midstream — Pretoria, Gauteng, South Africa
- Zuid Afrikaans Hospital — Pretoria, South Africa
Full record on ClinicalTrials.gov
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