Back to resultsOral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Primary Purpose
Mycoses, Candidiasis, Invasive, Candidemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SCY-078
Fluconazole
Micafungin
Sponsored by
About this trial
This is an interventional treatment trial for Mycoses focused on measuring Invasive Candidiasis, Invasive Candida infections, Candidemia, SCY-078, Micafungin, Fluconazole, Echinocandin
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alabama at Birmingham
- UC Davis Medical Center
- University of Colorado Denver
- University of Miami
- Georgia Regents University
- University of Chicago
- Johns Hopkins University School of Medicine
- Washington University School of Medicine
- Mercury Street Medical Group
- Albany Medical Center
- Montefiore Medical Center
- University of North Carolina
- Duke University Medical Center
- University of Pittsburgh Medical Center
- Rhode Island Hospital
- The Miriam Hospital
- Medical University of South Carolina
- Dallas VA Medical Center
- Parkland Hospital
- University of Texas Southwestern Medical Center
- University of Texas Health Science Center at Houston
- South Texas Veterans Healthcare System
- University of Texas Health Science Center at San Antonio
- University of Utah Hospitals and Clinics
- Hospital Militar Central
- Hospital Rosales
- University of Cologne
- Finca El Palomar
- Hospital Mario Catarino Rivas
- Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
SCY-078 500 mg
SCY-078 750 mg
Standard-of-care
Arm Description
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.
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.
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
Outcomes
Primary Outcome Measures
Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements
Dose of SCY-078 that achieves the target exposure (AUC)
Secondary Outcome Measures
Global response
Clinical response
Microbiological response
Relapse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02244606
Brief Title
Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses, Candidiasis, Invasive, Candidemia
Keywords
Invasive Candidiasis, Invasive Candida infections, Candidemia, SCY-078, Micafungin, Fluconazole, Echinocandin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCY-078 500 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
SCY-078 750 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard-of-care
Arm Type
Active Comparator
Arm Description
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
Intervention Type
Drug
Intervention Name(s)
SCY-078
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Type
Drug
Intervention Name(s)
Micafungin
Primary Outcome Measure Information:
Title
Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements
Time Frame
from time of informed consent through 6-weeks after last study drug
Title
Dose of SCY-078 that achieves the target exposure (AUC)
Time Frame
during randomized study drug (administered for a maximum of 23 days)
Secondary Outcome Measure Information:
Title
Global response
Time Frame
end of all antifungal therapy (administered for a maximum of 28 days)
Title
Clinical response
Time Frame
end of all antifungal therapy (administered for a maximum of 28 days)
Title
Microbiological response
Time Frame
end of all antifungal therapy (administered for a maximum of 28 days)
Title
Relapse
Time Frame
2-weeks and 6-weeks after the end of all antifungal therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Angulo, MD
Organizational Affiliation
Scynexis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Veterans Healthcare System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Hospitals and Clinics
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Hospital Militar Central
City
San Salvador
Country
El Salvador
Facility Name
Hospital Rosales
City
San Salvador
Country
El Salvador
Facility Name
University of Cologne
City
Cologne
State/Province
North Rhine Westphalia
Country
Germany
Facility Name
Finca El Palomar
City
Guatemala
ZIP/Postal Code
Zona 16
Country
Guatemala
Facility Name
Hospital Mario Catarino Rivas
City
San Pedro Sula
State/Province
Cortes
Country
Honduras
Facility Name
Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula
City
San Pedro Sula
State/Province
Cortes
Country
Honduras
12. IPD Sharing Statement
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Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
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