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Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) (CARES)

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ClinicalTrials.gov Identifier: NCT03363841
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Tracking Information
First Submitted Date  ICMJE November 14, 2017
First Posted Date  ICMJE December 6, 2017
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE November 15, 2017
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Official Title  ICMJE 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
Brief 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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
non comparator, single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis, Invasive
  • Candidemia
Intervention  ICMJE Drug: SCY-078
Oral SCY-078
Study Arms  ICMJE Experimental: SCY-078
SCY-078
Intervention: Drug: SCY-078
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2021
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must fulfill the following KEY criteria to be eligible for study admission:

    1. Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed.
    2. 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.
    3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.

Exclusion Criteria:

  • KEY exclusion criteria:

    1. Subject has a fungal disease with central nervous system involvement.
    2. Subject has a fungal disease of the bone and/or joint that is expected to require >90 days of study drug treatment.
    3. Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
    4. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support.
    5. 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.
    6. Subject has an Apache score >16.
    7. Subject has serum creatinine >3 times from Baseline (Screening/Treatment Day 1) value.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Angulo, MD 201-884-5471 david.angulo@scynexis.com
Contact: Mihaela Tufa, MD 201-884-5899 mihaela.tufa@scynexis.com
Listed Location Countries  ICMJE India,   Pakistan,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03363841
Other Study ID Numbers  ICMJE SCY-078-305
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Scynexis, Inc.
Study Sponsor  ICMJE Scynexis, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Angulo, MD Scynexis, Inc.
PRS Account Scynexis, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP