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

NCT ID: NCT03363841

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-15
• Study Completion Date: 2023-05-24

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)

Conditions

Candidiasis, Invasive; Candidemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCY-078

SCY-078

Group Type: EXPERIMENTAL

SCY-078

Intervention Type: DRUG

Oral SCY-078

Interventions

SCY-078

Oral SCY-078

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scynexis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Angulo, MD

Role: STUDY_DIRECTOR

Scynexis, Inc.

Locations

Scynexis, Inc.

Jersey City, New Jersey, United States

St John's Medical College and Hospital

Bangalore, Karnataka, India

Amrita Institute of Medical Sciences (AIMS)

Kanayannur, Kochi, India

Institute of Critical Care Medicine Max Super Specialty Hospital

Sāket, New Delhi, India

King George Medical University

Lucknow, Uttar Pradesh, India

Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care

Chandigarh, , India

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157

Centurion, Gauteng, 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, South Africa

Zuid Afrikaans Hospital

Pretoria, , South Africa

Countries

United States; India; Pakistan; South Africa

References

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.

Reference Type: BACKGROUND

PMID: 28483955 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28223375 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SCY-078-305

Identifier Type: -

Identifier Source: org_study_id