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

Candidemia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03363841
• Other study ID #: SCY-078-305
• Status: Completed
• Phase: Phase 3
• Start date: November 15, 2017
• Est. completion date: May 24, 2023

Study information

• Verified date: June 2023
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 24, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Candidiasis, Invasive

Intervention

Drug:
• SCY-078
Oral SCY-078

Locations

Country	Name	City	State
India	St John's Medical College and Hospital	Bangalore	Karnataka
India	Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care	Chandigarh
India	Amrita Institute of Medical Sciences (AIMS)	Kanayannur	Kochi
India	King George Medical University	Lucknow	Uttar Pradesh
India	Institute of Critical Care Medicine Max Super Specialty Hospital	Saket	New Delhi
Pakistan	Aga Khan University Hospital	Karachi	Sindh
South Africa	Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157	Centurion	Gauteng
South Africa	Zuid Afrikaans Hospital	Muckleneuck	Pretoria
South Africa	Emmed Research, Jakarta Hospital	Pretoria	Gauteng
South Africa	Into Research, Life Groenkloof Hospital	Pretoria	Gauteng
South Africa	Johese Clinical Research, Midstream	Pretoria	Gauteng
United States	Scynexis, Inc.	Jersey City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Countries where clinical trial is conducted

United States,  India,  Pakistan,  South Africa, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 90 days of study treatment
Secondary	Number of participants with treatment-related Adverse Events (Safety)	Number of participants with Adverse Events that are related to treatment	Through study completion, an average of 132 days
Secondary	Number of participants with Discontinuations due to Adverse Events (Safety)	Number of participants with Discontinuations due to Adverse Events	Through study completion, an average of 132 days
Secondary	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	up to 42 days after end of study treatment
Secondary	Survival (Safety and Efficacy)	Proportion of surviving subjects	Day 42 and Day 84