Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults
1 other identifier
interventional
27
5 countries
30
Brief Summary
The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2014
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 12, 2014
CompletedFirst Posted
Study publicly available on registry
September 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
June 25, 2024
CompletedJune 25, 2024
May 1, 2024
1.8 years
September 12, 2014
February 8, 2023
May 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
All Related TEAEs by SOC and PT, by Treatment, Safety
up to 10 weeks
Dose of SCY-078 That Achieves the Target Exposure (AUC)
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
0 to 24 hours post-dose
Secondary Outcomes (4)
Global Response
end of all antifungal therapy (administered for a maximum of 28 days)
Clinical Response
end of all antifungal therapy (administered for a maximum of 28 days)
Microbiological Response
end of all antifungal therapy (administered for a maximum of 28 days)
Relapse
2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks
Study Arms (3)
SCY-078 500 mg
EXPERIMENTALA single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
SCY-078 750 mg
EXPERIMENTALA single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
Standard-of-care
ACTIVE COMPARATOROral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
- Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.
You may not qualify if:
- Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
- Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
- Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
- Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scynexis, Inc.lead
Study Sites (30)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
University of Miami
Miami, Florida, 33125, United States
Georgia Regents University
Augusta, Georgia, 30912, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercury Street Medical Group
Butte, Montana, 59701, United States
Albany Medical Center
Albany, New York, 12208, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Parkland Hospital
Dallas, Texas, 75235, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
South Texas Veterans Healthcare System
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84112, United States
Hospital Militar Central
San Salvador, El Salvador
Hospital Rosales
San Salvador, El Salvador
University of Cologne
Cologne, North Rhine-Westphalia, Germany
Finca El Palomar
Guatemala City, Zona 16, Guatemala
Hospital Mario Catarino Rivas
San Pedro Sula, Cortés Department, Honduras
Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula
San Pedro Sula, Cortés Department, Honduras
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. David Angulo
- Organization
- SCYNEXIS
Study Officials
- STUDY DIRECTOR
David Angulo, MD
Scynexis, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2014
First Posted
September 19, 2014
Study Start
September 1, 2014
Primary Completion
June 1, 2016
Study Completion
August 1, 2016
Last Updated
June 25, 2024
Results First Posted
June 25, 2024
Record last verified: 2024-05