Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients … (NCT03363841) | Clinical Trial Compass
CompletedPhase 3
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
United States, India30 participantsStarted 2017-11-15
Plain-language 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 with a documented Candida auris infection.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 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.
What they're measuring
1
Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
Timeframe: At (EoT) Visit (up to 90 days after Day 1)