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.
A Phase 3, multicenter, prospective, randomized, double-blind, efficacy and safety study of Rezafungin for injection versus the standard antimicrobial regimen for the prevention of invasive fungal diseases in subjects undergoing allogeneic blood and marrow transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
602
Intravenous antifungal therapy
Oral antifungal therapy
Oral antifungal therapy
Oral antibacterial therapy
Normal saline
Microcrystalline cellulose
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
Noninferior Fungal-Free Survival (US FDA)
The number of subjects in each treatment group who are fungal-free and survive.
Time frame: Day 90 (±7 days)
Noninferior Fungal-Free Survival (US FDA)
The percentage of subjects in each treatment group who are fungal-free and survive.
Time frame: Day 90 (±7 days)
Superior Fungal-Free Survival (EMA)
The number of subjects in each treatment group who are fungal-free and survive.
Time frame: Day 90 (±7 days)
Superior Fungal-Free Survival (EMA)
The percentage of subjects in each treatment group who are fungal-free and survive.
Time frame: Day 90 (±7 days)
Compare Discontinuation for Toxicity or Intolerance
The number of subjects that discontinued Rezafungin for Injection compared to the standard antimicrobial regimen (SAR) secondary to toxicity or intolerance.
Time frame: Day 90 (±7 days)
Compare Discontinuation for Toxicity or Intolerance
The percentage of subjects that discontinued Rezafungin for Injection compared to the standard antimicrobial regimen (SAR) secondary to toxicity or intolerance.
Time frame: Day 90 (±7 days)
Compare Proven and Probable IFD
The number of subjects in each treatment group who have proven and probable IFD including the number of invasive infections from Candida spp., Aspergillus spp., and Pneumocystis jirovecii.
Time frame: Day 90 (±7 days)
Compare Proven and Probable IFD
The percentage of subjects in each treatment group who have proven and probable IFD including the number of invasive infections from Candida spp., Aspergillus spp., and Pneumocystis jirovecii.
Time frame: Day 90 (±7 days)
Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD
The number of subjects in each treatment group who are fungal-free survival with or without a diagnosis of clinically significant GVHD.
Time frame: Day 90 (±7 days)
Compare Fungal-Free Survival with or without a Diagnosis of Clinically Significant GVHD
The percentage of subjects in each treatment group who are fungal-free survival with or without a diagnosis of clinically significant GVHD.
Time frame: Day 90 (±7 days)
Compare Time to IFD, or Death
Evaluate time to IFD (proven or probable IFD) or death in subjects randomized to Rezafungin for Injection compared to the standard antimicrobial regimen (SAR).
Time frame: Day 90 (±7 days)
Compare Mortality
Evaluate overall mortality and attributable mortality, with and without adjustment for patient comorbidity indices, in subjects randomized to Rezafungin for Injection compared to the SAR.
Time frame: Day 1 through follow-up visit (Day 120)
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
The number of subjects with incidence of treatment emergent adverse events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.
Time frame: Day 1 through follow-up visit (Day 120)
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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
...and 43 more locations