The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.
To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
4
VL-2397
Voriconazole, Isavuconazole, or Liposomal amphotericin B
All-cause mortality (ACM)
Time frame: 4 weeks
ACM
Time frame: 6 weeks
Number of participants with adverse events
Number of participants with adverse events
Time frame: 6 weeks
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University of Alabama at Birmingham Hospital, Division of Infectious Diseases
Birmingham, Alabama, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases
Sacramento, California, United States
Christiana Care Health Services, Department of Medicine
Newark, Delaware, United States
Medical College of Georgia at Augusta University
Augusta, Georgia, United States
DMC Harper University Hospital
Detroit, Michigan, United States
University of Minnesota, Department of Medicine
Minneapolis, Minnesota, United States
Washington University School of Medicine, Division of Infectious Disease
St Louis, Missouri, United States
The University of Texas Health Science Center, Department of Internal Medicine
Houston, Texas, United States
Fred Hutchinson Cancer Research Center (FHCRC)
Seattle, Washington, United States
...and 18 more locations