Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) (CARES)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03363841 |
Recruitment Status :
Recruiting
First Posted : December 6, 2017
Last Update Posted : December 15, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | N/A |
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 Ibrexafungerp (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 : | February 15, 2023 |
Estimated Study Completion Date : | April 15, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: SCY-078
SCY-078
|
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:
-
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.

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 | |
St John's Medical College and Hospital | Recruiting |
Bangalore, Karnataka, India, 560034 | |
Contact: Alekya Vemula 8897752905 hemtrials.stjohns@sjri.res.in | |
Principal Investigator: Ross C Reuben, MD | |
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 | |
Institute of Critical Care Medicine Max Super Specialty Hospital | Recruiting |
Saket, New Delhi, India, 110017 | |
Contact: Komal Handa 7888600688 Komal2@maxhealthcare.com | |
Principal Investigator: Deven Juneja, MD | |
King George Medical University | Recruiting |
Lucknow, Uttar Pradesh, India, 226003 | |
Contact: Om Narayan clinicreseacrhko@gmail.com | |
Principal Investigator: Dr. Sulekha Saxena | |
Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care | Recruiting |
Chandigarh, India, 160012 | |
Contact: Narayana Yaddanapudi, MD 9815836656 narayana.yaddanapudi@gmail.com | |
Principal Investigator: Narayana Yaddanapudi, MD | |
Pakistan | |
Aga Khan University Hospital | Recruiting |
Karachi, Sindh, Pakistan, 74800 | |
Contact: Mahmood Syed Faisal, MD +92 21 3486 4655 | |
South Africa | |
Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157 | Recruiting |
Centurion, Gauteng, South Africa, 0157 | |
Contact: Helga Fourie helga@johese.co.za | |
Principal Investigator: Martie Conradie, MD | |
Emmed Research, Jakarta Hospital | Recruiting |
Pretoria, Gauteng, South Africa, 0002 | |
Contact: Marlet Cronje marlet@clinres.co.za | |
Principal Investigator: Dr. Hannes Breedt | |
Into Research, Life Groenkloof Hospital | Recruiting |
Pretoria, Gauteng, South Africa, 0181 | |
Contact: Ria Booysen ria@internists.co.za | |
Principal Investigator: Dr. Richard S. Sebert | |
Johese Clinical Research, Midstream | Recruiting |
Pretoria, Gauteng, South Africa, 1692 | |
Contact: Helga Fourie helga@johese.co.za | |
Principal Investigator: Dr. Martie Conradie |
Study Director: | David Angulo, MD | Scynexis, Inc. |
Responsible Party: | Scynexis, Inc. |
ClinicalTrials.gov Identifier: | NCT03363841 |
Other Study ID Numbers: |
SCY-078-305 |
First Posted: | December 6, 2017 Key Record Dates |
Last Update Posted: | December 15, 2022 |
Last Verified: | December 2022 |
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 |
Candida auris |
Candidiasis Candidemia Candidiasis, Invasive Mycoses Bacterial Infections and Mycoses Infections Invasive Fungal Infections Fungemia |
Sepsis Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Ibrexafungerp Antifungal Agents Anti-Infective Agents |