A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
- Conditions
- Candidiasis, InvasiveCandidemia
- Interventions
- Registration Number
- NCT05178862
- Lead Sponsor
- Scynexis, Inc.
- Brief Summary
This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 220
- Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
- Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).
Key
-
Subject has any of the following forms of invasive candidiasis at Screening:
- Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
- Osteomyelitis,
- Endocarditis or myocarditis,
- Meningitis, endophthalmitis, or any central nervous system infection,
- Chronic disseminated candidiasis,
- Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
- Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
- Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
- Patients who failed a previous antifungal therapy for the same infection,
- Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
-
Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
-
Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).
-
Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
-
Baseline QTcF ≥ 500 msec.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV echinocandin followed by oral ibrexafungerp (SCY-078) SCY-078 - IV echinocandin followed by oral ibrexafungerp (SCY-078) Echinocandin - IV echinocandin followed by oral fluconazole Fluconazole - IV echinocandin followed by oral fluconazole Echinocandin -
- Primary Outcome Measures
Name Time Method Global Response at End of Treatment (EU European Medicines Agency [EMA] Only) Up to 6 weeks The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
All-cause mortality (US FDA Only) Day 30 The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
- Secondary Outcome Measures
Name Time Method Global Response at Day 14 Day 14 The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Trial Locations
- Locations (72)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Saint Luc University Hospital
🇧🇪Brussels, Belgium
University Hospitals Leuven, Campus Gasthuisberg
🇧🇪Leuven, Belgium
Mediclinic Victoria
🇿🇦Tongaat, KwaZulu-Natal, South Africa
Duke University
🇺🇸Durham, North Carolina, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Banner University Medical Center-Tucson
🇺🇸Tucson, Arizona, United States
Augusta University Medical Center
🇺🇸Augusta, Georgia, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
University of Pennsylvania School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
LAIKO General Hospital
🇬🇷Athens, Greece
University Health Network- Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery
🇧🇬Plovdiv, Bulgaria
Paris University Hospitals Center- Cochin Hospital
🇫🇷Paris, France
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
🇧🇬Stara Zagora, Bulgaria
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery
🇧🇬Sofia, Bulgaria
University Hospital Center of Poitiers
🇫🇷Poitiers, France
Rambam Health Care Campus, Institute of Infectious Diseases
🇮🇱Haifa, Israel
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Lady Davis Carmel Medical Center, Infectious Diseases Unit
🇮🇱Haifa, Israel
IRCCS- University Hospital San Martino-IST
🇮🇹Genoa, Liguria, Italy
Big Metropolitan Hospital Niguarda Regional Health Authority
🇮🇹Milan, Italy
University Polyclinic Hospital of Modena
🇮🇹Modena, Italy
Central Friuli University Healthcare Company
🇮🇹Udine, Italy
University Hospital de La Princesa
🇪🇸Madrid, Spain
University Clinical Hospital of Valencia
🇪🇸Valencia, Spain
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
University Hospital Ghent
🇧🇪Ghent, Belgium
Nantes University Hospital Center
🇫🇷Nantes, France
Victor Dupouy Hospital Center Argenteuil
🇫🇷Argenteuil, France
University Hospital Freiburg
🇩🇪Freiburg, Baden-Wuerttemberg, Germany
Saint-Louis Hospital
🇫🇷Paris, France
Univeristy Hospital Jena
🇩🇪Jena, Thuringia, Germany
University Hospital Cologne
🇩🇪Cologne, Germany
Frankfurt University Clinic
🇩🇪Frankfurt, Germany
Municipal Hospital Munich GMbH/Hospital Neuperlach
🇩🇪Munich, Germany
Helios Clinic Wuppertal
🇩🇪Wuppertal, Germany
General Hospital of Athens "Evangelismos", 1st Department of Critical Care
🇬🇷Athens, Greece
University General Hospital "Attikon"
🇬🇷Athens, Greece
General Hospital of Athens "Evangelismos"
🇬🇷Athens, Greece
General Hospital of Thessaloniki "Ippokratio"
🇬🇷Thessaloníki, Greece
CHA Bundang Medical Center, CHA University
🇰🇷Gyeonggi-do, Korea, Republic of
Chaim Sheba Medical Center
🇮🇱Tel HaShomer, Israel
Keimyung University - Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Zuid-Afrikaans Hospital
🇿🇦Pretoria, Gauteng, South Africa
Netcare Jakaranda Hospital
🇿🇦Pretoria, Gauteng, South Africa
Lakeview Hospital
🇿🇦Benoni, Gauteng, South Africa
Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Life Groenkloof Hospital
🇿🇦Pretoria, Gauteng, South Africa
FCRN Clinical Trials Centre
🇿🇦Vereeniging, Gauteng, South Africa
Hospital del Mar Medical Research Institute (IMIM)
🇪🇸Barcelona, Catalonia, Spain
University and Polytechnic Hospital La Fe
🇪🇸Valencia, Spain
General University Hospital Gregorio Maranon
🇪🇸Madrid, Spain
University of Pretoria and Steve Biko Academic Hospital
🇿🇦Pretoria, South Africa
University Hospital Virgen Macarena
🇪🇸Seville, Andalusia, Spain
University Hospital Puerta de Hierro Majadahonda
🇪🇸Madrid, Spain
University of Alabama at Birmingham School of Medicine
🇺🇸Birmingham, Alabama, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States