Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients With Candidiasis Caused by Candida Auris (CARES) (CARES)
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| ClinicalTrials.gov Identifier: NCT03363841 |
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Recruitment Status :
Recruiting
First Posted : December 6, 2017
Last Update Posted : September 25, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Candidiasis, Invasive Candidemia | Drug: SCY-078 | Phase 3 |
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 years of age with a documented Candida auris infection. Patients will be treated with SCY-078 for up to 90 days.
Subjects must have a documented candidiasis, including candidemia, caused by Candida auris to be considered for enrollment. Subjects are also eligible if they are receiving intravenous (IV) antifungal therapy for their C. auris infection and, in the judgment of the investigator, continued IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. Subjects must meet all study criteria to be eligible for inclusion. Inclusion of each subject in the study must be approved by the Sponsor prior to enrollment.
Following a screening visit , there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts (survival visits)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | non comparator, single arm |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral SCY-078 as an Emergency Use Treatment for Patients With Candidiasis, Including Candidemia, Caused by Candida Auris |
| Actual Study Start Date : | November 15, 2017 |
| Estimated Primary Completion Date : | November 15, 2020 |
| Estimated Study Completion Date : | May 15, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: SCY-078
SCY-078
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Drug: SCY-078
Oral SCY-078 |
- Efficacy as measured by the percentage of subjects with global success at end of treatment [ Time Frame: Up to 90 days of study treatment ]Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the Data Monitoring Committee
- Number of participants with treatment-related Adverse Events (Safety) [ Time Frame: Through study completion, an average of 132 days ]Number of participants with Adverse Events that are related to treatment
- Number of participants with Discontinuations due to Adverse Events (Safety) [ Time Frame: Through study completion, an average of 132 days ]Number of participants with Discontinuations due to Adverse Events
- Recurrence of Baseline Fungal Infection (Efficacy) [ Time Frame: up to 42 days after end of study treatment ]Assessment of Recurrence of Baseline Fungal Infection The proportion of subjects with a recurrence of the baseline fungal infection
- Survival (Safety and Efficacy) [ Time Frame: Day 42 and Day 84 ]Proportion of surviving subjects
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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:
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363841
| Contact: David Angulo, MD | 201-884-5471 | david.angulo@scynexis.com | |
| Contact: Mihaela Tufa, MD | 201-884-5899 | mihaela.tufa@scynexis.com |
| United States, New Jersey | |
| Scynexis, Inc. | Recruiting |
| Jersey City, New Jersey, United States, 07302 | |
| Contact: David Angulo, MD 201-884-5471 david.angulo@scynexis.com | |
| India | |
| Amrita Institute of Medical Sciences (AIMS) | Recruiting |
| Kanayannur, Kochi, India, 682041 | |
| Contact: Puneet Dhar, MD 484-9447736769 pdhar@aims.amrita.cdu | |
| Contact: Deepa Gijesh 484-9995184399 deepagijesh@aims.amrita.edu | |
| Study Director: | David Angulo, MD | Scynexis, Inc. |
Publications:
| Responsible Party: | Scynexis, Inc. |
| ClinicalTrials.gov Identifier: | NCT03363841 History of Changes |
| Other Study ID Numbers: |
SCY-078-305 |
| First Posted: | December 6, 2017 Key Record Dates |
| Last Update Posted: | September 25, 2018 |
| Last Verified: | September 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Scynexis, Inc.:
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Candida auris |
Additional relevant MeSH terms:
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Candidiasis Candidemia Candidiasis, Invasive Mycoses Fungemia Sepsis |
Infection Invasive Fungal Infections Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |