Clinical trial NCT03363841: 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: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Candidiasis, Invasive
Candidemia
Keywords: Candida auris
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: non comparator, single arm
Primary purpose: TREATMENT

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)

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:

* 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.

Primary outcomes:
measure: Percentage of Participants With Global Success at End of Treatment as Determined by the Data Monitoring Committee
timeFrame: At (EoT) Visit (up to 90 days after Day 1)
Secondary outcomes:
measure: Percent of Participants With Treatment-emergent Adverse Events
timeFrame: Through study completion, up to 132 days
measure: Number of Participants Discontinued Due to Adverse Events
timeFrame: Through study completion (up to 132 Days)
measure: Percentage of Participants With Recurrence of Baseline Fungal Infection
timeFrame: 42 Days after the End of Treatment visit
measure: Percentage of Participants Surviving 42 and 84 Days
timeFrame: Day 42 and Day 84 after first dose of study drug
Other outcomes:
Locations:
city: Jersey City
country: United States
facility: Scynexis, Inc.
state: New Jersey
city: Bangalore
country: India
facility: St John's Medical College and Hospital
state: Karnataka
city: Kanayannur
country: India
facility: Amrita Institute of Medical Sciences (AIMS)
state: Kochi
city: Saket
country: India
facility: Institute of Critical Care Medicine Max Super Specialty Hospital
state: New Delhi
city: Lucknow
country: India
facility: King George Medical University
state: Uttar Pradesh
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research, Department of Anaesthesia and special care
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
city: Centurion
country: South Africa
facility: Johese Clinical Research, Unitas Hospital Centurion,, South Africa, 0157
state: Gauteng
city: Pretoria
country: South Africa
facility: Emmed Research, Jakarta Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Into Research, Life Groenkloof Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Johese Clinical Research, Midstream
state: Gauteng
city: Pretoria
country: South Africa
facility: Zuid Afrikaans Hospital
Study officials:
affiliation: Scynexis, Inc.
name: David Angulo, MD
role: STUDY_DIRECTOR
References:
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.
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.