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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)

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 2, 2019
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Candidiasis, Invasive Candidemia Drug: SCY-078 Phase 3

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 Design
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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 : November 15, 2020
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arms and Interventions
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Arm Intervention/treatment
Experimental: SCY-078
SCY-078
 Drug: SCY-078
Oral SCY-078


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Survival (Safety and Efficacy) [ Time Frame: Day 42 and Day 84 ]
    Proportion of surviving subjects


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: David Angulo, MD 201-884-5471 david.angulo@scynexis.com
Contact: Mihaela Tufa, MD 201-884-5899 mihaela.tufa@scynexis.com

Locations
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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         
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 Not yet recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Mahmood Syed Faisal, MD    +92 21 3486 4655      
Sponsors and Collaborators
Scynexis, Inc.
Investigators
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Study Director: David Angulo, MD Scynexis, Inc.
More Information
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Publications:

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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 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scynexis, Inc.:
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