Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
- Conditions
- MycosesCandidiasis, InvasiveCandidemia
- Interventions
- Registration Number
- NCT02244606
- Lead Sponsor
- Scynexis, Inc.
- 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.
- Detailed Description
Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SCY-078 500 mg SCY-078 A 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 SCY-078 A 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 Fluconazole Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily. Standard-of-care Micafungin Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
- Primary Outcome Measures
Name Time Method Dose of SCY-078 That Achieves the Target Exposure (AUC) 0 to 24 hours post-dose Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements up to 10 weeks All Related TEAEs by SOC and PT, by Treatment, Safety
- Secondary Outcome Measures
Name Time Method Global Response end of all antifungal therapy (administered for a maximum of 28 days) Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)
Clinical Response end of all antifungal therapy (administered for a maximum of 28 days) Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy
Microbiological Response end of all antifungal therapy (administered for a maximum of 28 days) Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection
Relapse 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered
Trial Locations
- Locations (30)
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
South Texas Veterans Healthcare System
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Mercury Street Medical Group
🇺🇸Butte, Montana, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Albany Medical Center
🇺🇸Albany, New York, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Parkland Hospital
🇺🇸Dallas, Texas, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Cologne
🇩🇪Cologne, North Rhine Westphalia, Germany
Finca El Palomar
🇬🇹Guatemala, Guatemala
Hospital Mario Catarino Rivas
🇭🇳San Pedro Sula, Cortes, Honduras
Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula
🇭🇳San Pedro Sula, Cortes, Honduras
University of Utah Hospitals and Clinics
🇺🇸Salt Lake City, Utah, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Hospital Rosales
🇸🇻San Salvador, El Salvador
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Hospital Militar Central
🇸🇻San Salvador, El Salvador