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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05178862
Other study ID # SCY-078-302
Secondary ID MSG-20
Status Suspended
Phase Phase 3
First received
Last updated
Start date August 3, 2022
Est. completion date August 2024

Study information

Verified date November 2023
Source Scynexis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 220
Est. completion date August 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - 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 Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Drug:
SCY-078
Oral ibrexafungerp (SCY-078) as step-down therapy.
Fluconazole
Oral fluconazole (SCY-078) as step-down therapy.
Echinocandin
Intravenous echinocandin

Locations

Country Name City State
Belgium Saint Luc University Hospital Brussels
Belgium University Hospital Ghent Ghent
Belgium University Hospitals Leuven, Campus Gasthuisberg Leuven
Bulgaria University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery Plovdiv
Bulgaria University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery Sofia
Bulgaria University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" Stara Zagora
Canada McGill University Health Centre Montréal Quebec
Canada Princess Margaret Hospital Toronto Ontario
Canada University Health Network- Toronto General Hospital Toronto Ontario
France Victor Dupouy Hospital Center Argenteuil Argenteuil
France Nantes University Hospital Center Nantes
France Paris University Hospitals Center- Cochin Hospital Paris
France Saint-Louis Hospital Paris
France University Hospital Center of Poitiers Poitiers
Germany University Hospital Cologne Cologne
Germany Frankfurt University Clinic Frankfurt
Germany University Hospital Freiburg Freiburg Baden-Wuerttemberg
Germany Univeristy Hospital Jena Jena Thuringia
Germany Municipal Hospital Munich GMbH/Hospital Neuperlach Munich
Germany Helios Clinic Wuppertal Wuppertal
Greece General Hospital of Athens "Evangelismos" Athens
Greece General Hospital of Athens "Evangelismos", 1st Department of Critical Care Athens
Greece LAIKO General Hospital Athens
Greece University General Hospital "Attikon" Athens
Greece General Hospital of Thessaloniki "Ippokratio" Thessaloníki
Israel Lady Davis Carmel Medical Center, Infectious Diseases Unit Haifa
Israel Rambam Health Care Campus, Institute of Infectious Diseases Haifa
Israel Chaim Sheba Medical Center Tel HaShomer
Italy 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
Korea, Republic of Keimyung University - Dongsan Medical Center Daegu
Korea, Republic of CHA Bundang Medical Center, CHA University Gyeonggi-do
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Wonju Severance Christian Hospital Wonju
South Africa Lakeview Hospital Benoni Gauteng
South Africa Life Groenkloof Hospital Pretoria Gauteng
South Africa Netcare Jakaranda Hospital Pretoria Gauteng
South Africa University of Pretoria and Steve Biko Academic Hospital Pretoria
South Africa Zuid-Afrikaans Hospital Pretoria Gauteng
South Africa Mediclinic Victoria Tongaat KwaZulu-Natal
South Africa FCRN Clinical Trials Centre Vereeniging Gauteng
Spain Hospital del Mar Medical Research Institute (IMIM) Barcelona Catalonia
Spain General University Hospital Gregorio Maranon Madrid
Spain University Hospital de La Princesa Madrid
Spain University Hospital Puerta de Hierro Majadahonda Madrid
Spain University Hospital Virgen Macarena Seville Andalusia
Spain University and Polytechnic Hospital La Fe Valencia
Spain University Clinical Hospital of Valencia Valencia
United States University of Michigan Hospital Ann Arbor Michigan
United States Augusta University Medical Center Augusta Georgia
United States Johns Hopkins Hospital Baltimore Maryland
United States University of Maryland Medical Center Baltimore Maryland
United States University of Alabama at Birmingham School of Medicine Birmingham Alabama
United States Mercury Street Medical Group, PLLC Butte Montana
United States University of Chicago Chicago Illinois
United States Henry Ford Hospital Detroit Michigan
United States Duke University Durham North Carolina
United States University of Texas Health Science Center at Houston Houston Texas
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Ochsner Medical Center New Orleans Louisiana
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States The Miriam Hospital Providence Rhode Island
United States Mayo Clinic - Rochester Rochester Minnesota
United States UC Davis Medical Center Sacramento California
United States Washington University School of Medicine Saint Louis Missouri
United States LSU Health Sciences Center Shreveport Louisiana
United States Banner University Medical Center-Tucson Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Scynexis, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Greece,  Israel,  Italy,  Korea, Republic of,  South Africa,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality (US FDA Only) The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population. Day 30
Primary Global Response at End of Treatment (EU European Medicines Agency [EMA] Only) The percentage of subjects with Successful Global Response, as determined by the Data Review Committee Up to 6 weeks
Secondary Global Response at Day 14 The percentage of subjects with Successful Global Response, as determined by the Data Review Committee Day 14
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