A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

Who is this study for? Patients with Candidemia
What treatments are being studied? Echinocandin
Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alabama
University of Alabama at Birmingham School of Medicine
RECRUITING
Birmingham
Arizona
Banner University Medical Center-Tucson
NOT_YET_RECRUITING
Tucson
California
UC Davis Medical Center
RECRUITING
Sacramento
Colorado
University of Colorado Anschutz Medical Campus
RECRUITING
Denver
Georgia
Augusta University Medical Center
RECRUITING
Augusta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Louisiana
Ochsner Medical Center
RECRUITING
New Orleans
LSU Health Sciences Center
NOT_YET_RECRUITING
Shreveport
Maryland
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
University of Maryland Medical Center
NOT_YET_RECRUITING
Baltimore
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Minnesota
University of Minnesota Medical Center
RECRUITING
Minneapolis
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Montana
Mercury Street Medical Group, PLLC
NOT_YET_RECRUITING
Butte
North Carolina
Duke University
RECRUITING
Durham
Pennsylvania
University of Pennsylvania School of Medicine
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
NOT_YET_RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
WITHDRAWN
Providence
The Miriam Hospital
WITHDRAWN
Providence
Texas
University of Texas Health Science Center at Houston
RECRUITING
Houston
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Other Locations
Belgium
Saint Luc University Hospital
NOT_YET_RECRUITING
Brussels
University Hospital Ghent
NOT_YET_RECRUITING
Ghent
University Hospitals Leuven, Campus Gasthuisberg
NOT_YET_RECRUITING
Leuven
Bulgaria
University Multiprofile Hospital for Active Treatment Eurohospital Plovdiv, Plovdiv, Department of Surgery
NOT_YET_RECRUITING
Plovdiv
University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov, Sofia, Clinic of Purulent-Septic Surgery
NOT_YET_RECRUITING
Sofia
University Multiprofile Hospital for Active Treatment Prof. Dr. Stoyan Kirkovich
NOT_YET_RECRUITING
Stara Zagora
Canada
McGill University Health Centre
NOT_YET_RECRUITING
Montreal
Princess Margaret Hospital
NOT_YET_RECRUITING
Toronto
University Health Network- Toronto General Hospital
NOT_YET_RECRUITING
Toronto
France
Victor Dupouy Hospital Center Argenteuil
NOT_YET_RECRUITING
Argenteuil
Nantes University Hospital Center
NOT_YET_RECRUITING
Nantes
Paris University Hospitals Center- Cochin Hospital
NOT_YET_RECRUITING
Paris
Saint-Louis Hospital
NOT_YET_RECRUITING
Paris
University Hospital Center of Poitiers
TERMINATED
Poitiers
Germany
University Hospital Cologne
NOT_YET_RECRUITING
Cologne
Frankfurt University Clinic
NOT_YET_RECRUITING
Frankfurt
University Hospital Freiburg
NOT_YET_RECRUITING
Freiburg Im Breisgau
Univeristy Hospital Jena
NOT_YET_RECRUITING
Jena
Municipal Hospital Munich GMbH/Hospital Neuperlach
TERMINATED
Munich
Helios Clinic Wuppertal
NOT_YET_RECRUITING
Wuppertal
Greece
General Hospital of Athens Evangelismos
NOT_YET_RECRUITING
Athens
General Hospital of Athens Evangelismos, 1st Department of Critical Care
NOT_YET_RECRUITING
Athens
LAIKO General Hospital
NOT_YET_RECRUITING
Athens
University General Hospital Attikon
NOT_YET_RECRUITING
Athens
General Hospital of Thessaloniki Ippokratio
NOT_YET_RECRUITING
Thessaloniki
Israel
Lady Davis Carmel Medical Center, Infectious Diseases Unit
NOT_YET_RECRUITING
Haifa
Rambam Health Care Campus, Institute of Infectious Diseases
NOT_YET_RECRUITING
Haifa
Chaim Sheba Medical Center
NOT_YET_RECRUITING
Tel Litwinsky
Italy
IRCCS- University Hospital San Martino-IST
NOT_YET_RECRUITING
Genoa
Big Metropolitan Hospital Niguarda Regional Health Authority
NOT_YET_RECRUITING
Milan
University Polyclinic Hospital of Modena
NOT_YET_RECRUITING
Modena
Central Friuli University Healthcare Company
NOT_YET_RECRUITING
Udine
Republic of Korea
Keimyung University - Dongsan Medical Center
NOT_YET_RECRUITING
Daegu
CHA Bundang Medical Center, CHA University
NOT_YET_RECRUITING
Gyeonggi-do
Gangnam Severance Hospital
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
Wonju Severance Christian Hospital
NOT_YET_RECRUITING
Wŏnju
South Africa
Lakeview Hospital
NOT_YET_RECRUITING
Benoni
Life Groenkloof Hospital
NOT_YET_RECRUITING
Pretoria
Netcare Jakaranda Hospital
NOT_YET_RECRUITING
Pretoria
University of Pretoria and Steve Biko Academic Hospital
NOT_YET_RECRUITING
Pretoria
Zuid-Afrikaans Hospital
NOT_YET_RECRUITING
Pretoria
Mediclinic Victoria
NOT_YET_RECRUITING
Tongaat
FCRN Clinical Trials Centre
NOT_YET_RECRUITING
Vereeniging
Spain
Hospital del Mar Medical Research Institute (IMIM)
NOT_YET_RECRUITING
Barcelona
General University Hospital Gregorio Maranon
NOT_YET_RECRUITING
Madrid
University Hospital de La Princesa
NOT_YET_RECRUITING
Madrid
University Hospital Puerta de Hierro Majadahonda
NOT_YET_RECRUITING
Madrid
University Hospital Virgen Macarena
NOT_YET_RECRUITING
Seville
University and Polytechnic Hospital La Fe
NOT_YET_RECRUITING
Valencia
University Clinical Hospital of Valencia
NOT_YET_RECRUITING
Valencia
Contact Information
Primary
David Angulo, MD
david.angulo@scynexis.com
+1 201-884-5471
Backup
Misha Binder
Misha.Binder@scynexis.com
Time Frame
Start Date: 2022-08-03
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 220
Treatments
Experimental: IV echinocandin followed by oral ibrexafungerp (SCY-078)
Active_comparator: IV echinocandin followed by oral fluconazole
Related Therapeutic Areas
Sponsors
Leads: Scynexis, Inc.

This content was sourced from clinicaltrials.gov