A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.
Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous
fungi remain to be a life threatening diseases. Early treatment with highly effective
anti-fungals reduces mortality. Isavuconazole is not yet registered for the treatment of
fungal infections. This study investigates the efficacy and safety of isavuconazole in the
treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.
Patients are randomized to receive either isavuconazole or voriconazole. The study compares
the safety and efficacy of both drugs.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
All-cause mortality through Day 42
Up to Day 42
Astellas Pharma Global Development
United States: Food and Drug Administration
|University of Alabama||Birmingham, Alabama|
|Infectious Disease of Indiana||Indianapolis, Indiana 46218|
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|
|University of California at San Francisco||San Francisco, California 94115|
|University of Chicago, Division of Infectious Diseases||Chicago, Illinois 60637|
|Indiana BMT||Springfield, Illinois 62701|
|Brigham & Womens Hospital||Boston, Massachusetts 02115|
|Upstate Infectious Diseases Association LLP||Albany, New York 12208|
|Regional Infection Diseases Infusion Center Inc.||Lima, Ohio 45801|
|Springfield Clinic LLP||Springfield, Illinois 62703|