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Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation
Sponsor: Mundipharma Research Limited
Summary
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.
Official title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
602
Start Date
2020-05-11
Completion Date
2026-02
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Rezafungin for Injection
Intravenous antifungal therapy
Posaconazole
Oral antifungal therapy
Fluconazole
Oral antifungal therapy
Trimethoprim-sulfamethoxazole (TMP/SMX)
Oral antibacterial therapy
Intravenous Placebo
Normal saline
Oral Placebo
Microcrystalline cellulose
Locations (53)
University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA Center for Health Sciences
Los Angeles, California, United States
Stanford University School of Medicine
Stanford, California, United States
Augusta University Medical Center
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
John Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota Physicians
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Mary Hitchcock Memorial Hospital Dartmouth-Hitchcock
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
The University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
VCU Medical Center Main Hospital
Richmond, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
AZ Sint-Jan
Bruges, West Vlaanderen, Belgium
University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven
Leuven, Belgium
Hamilton Health Sciences' Juravinski Hospital
Hamilton, Canada
McGill University Health Center
Montreal, Canada
Jean Minjoz Hospital
Besançon, France
Henri Mondor Hospital
Créteil, France
Grenoble Alpes University Hospital Center
Grenoble, France
University Hospital of Limoges
Limoges, France
University Hospital of Nantes
Nantes, France
Hospital Saint Antoine Ap-Hp
Paris, France
University Hospital of Bordeaux
Pessac, France
Lyon-Sud Hospital Center
Pierre-Bénite, France
University Hospital of Cologne
Cologne, Germany
University Hospital Carl Gustav Carus Dresden
Dresden, Germany
Johannes Gutenberg University Medical Center
Mainz, Germany
University Hospital Münster
Münster, Germany
University Hospital Wurzburg UKW
Würzburg, Germany
San Martino Polyclinic Hospital
Genova, Italy
IEO Istituto Europeo di Oncologia
Milan, Italy
Agostino Gemelli University Policlinic
Rome, Italy
Humanitas Cancer Center
Rozzano, Italy
University Hospital Vall d'Hebron
Barcelona, Spain
Hospital Clinic of Barcelona
Barcelona, Spain
University Hospital Ramon y Cajal
Madrid, Spain
Puerta de Hierro Majadahonda University Hospital
Majadahonda, Spain
University Hospital of Salamanca
Salamanca, Spain
University Hospital Marques de Valdecilla
Santander, Spain
University Hospital of Valencia
Valencia, Spain
La Fe University and Polytechnic Hospital
Valencia, Spain
University Hospitals Geneva
Geneva, Switzerland
Addenbrookes Hospital
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Kings College Hospital NHS Foundation Trust
London, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, United Kingdom
The Royal Marsden Nhs Foundation Trust
London, United Kingdom