Phase 3
N=30
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Candidiasis, Invasive · Candidemia
Bottom Line
View on ClinicalTrials.gov: NCT03363841 ↗Enrolled (actual)
30
Serious AEs
36.7%
Results posted
Jul 2024
Primary outcome: Primary: Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee — 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SCY-078 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Scynexis, Inc.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee |
21 | — |
| SECONDARY Percent of Participants With Treatment-emergent Adverse Events |
25 | — |
| SECONDARY Number of Participants Discontinued Due to Adverse Events |
1 | — |
| SECONDARY Percentage of Participants With Recurrence of Baseline Fungal Infection |
1 | — |
| SECONDARY Percentage of Participants Surviving 42 and 84 Days |
24; 4; 2; 19; 8; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03363841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.