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, India, Pakistan30 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)
. 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.