Back to resultsOpen-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES) (CARES)
Primary Purpose
Candidiasis, Invasive, Candidemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SCY-078
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis, Invasive focused on measuring Candida auris
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.
Sites / Locations
- Scynexis, Inc.
- St John's Medical College and Hospital
- Amrita Institute of Medical Sciences (AIMS)
- Institute of Critical Care Medicine Max Super Specialty Hospital
- King George Medical University
- Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care
- Aga Khan University Hospital
- Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157
- Emmed Research, Jakarta Hospital
- Into Research, Life Groenkloof Hospital
- Johese Clinical Research, Midstream
- Zuid Afrikaans Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SCY-078
Arm Description
SCY-078
Outcomes
Primary Outcome Measures
Efficacy as measured by the percentage of subjects with global success at end of 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
Number of participants with treatment-related Adverse Events (Safety)
Number of participants with Adverse Events that are related to treatment
Number of participants with Discontinuations due to Adverse Events (Safety)
Number of participants with Discontinuations due to Adverse Events
Recurrence of Baseline Fungal Infection (Efficacy)
Assessment of Recurrence of Baseline Fungal Infection The proportion of subjects with a recurrence of the baseline fungal infection
Survival (Safety and Efficacy)
Proportion of surviving subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03363841
Brief Title
Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)
Acronym
CARES
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
May 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Invasive, Candidemia
Keywords
Candida auris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
non comparator, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCY-078
Arm Type
Experimental
Arm Description
SCY-078
Intervention Type
Drug
Intervention Name(s)
SCY-078
Intervention Description
Oral SCY-078
Primary Outcome Measure Information:
Title
Efficacy as measured by the percentage of subjects with global success at end of treatment
Description
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
Time Frame
Up to 90 days of study treatment
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related Adverse Events (Safety)
Description
Number of participants with Adverse Events that are related to treatment
Time Frame
Through study completion, an average of 132 days
Title
Number of participants with Discontinuations due to Adverse Events (Safety)
Description
Number of participants with Discontinuations due to Adverse Events
Time Frame
Through study completion, an average of 132 days
Title
Recurrence of Baseline Fungal Infection (Efficacy)
Description
Assessment of Recurrence of Baseline Fungal Infection The proportion of subjects with a recurrence of the baseline fungal infection
Time Frame
up to 42 days after end of study treatment
Title
Survival (Safety and Efficacy)
Description
Proportion of surviving subjects
Time Frame
Day 42 and Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Angulo, MD
Organizational Affiliation
Scynexis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scynexis, Inc.
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07302
Country
United States
Facility Name
St John's Medical College and Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
Amrita Institute of Medical Sciences (AIMS)
City
Kanayannur
State/Province
Kochi
ZIP/Postal Code
682041
Country
India
Facility Name
Institute of Critical Care Medicine Max Super Specialty Hospital
City
Saket
State/Province
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
King George Medical University
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Facility Name
Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157
City
Centurion
State/Province
Gauteng
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Emmed Research, Jakarta Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Into Research, Life Groenkloof Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Johese Clinical Research, Midstream
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
1692
Country
South Africa
Facility Name
Zuid Afrikaans Hospital
City
Muckleneuck
State/Province
Pretoria
ZIP/Postal Code
0002
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28483955
Citation
Berkow EL, Angulo D, Lockhart SR. In Vitro Activity of a Novel Glucan Synthase Inhibitor, SCY-078, against Clinical Isolates of Candida auris. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00435-17. doi: 10.1128/AAC.00435-17. Print 2017 Jul. No abstract available.
Results Reference
background
PubMed Identifier
28223375
Citation
Larkin E, Hager C, Chandra J, Mukherjee PK, Retuerto M, Salem I, Long L, Isham N, Kovanda L, Borroto-Esoda K, Wring S, Angulo D, Ghannoum M. The Emerging Pathogen Candida auris: Growth Phenotype, Virulence Factors, Activity of Antifungals, and Effect of SCY-078, a Novel Glucan Synthesis Inhibitor, on Growth Morphology and Biofilm Formation. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02396-16. doi: 10.1128/AAC.02396-16. Print 2017 May.
Results Reference
background
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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)
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