Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis



Status:Completed
Conditions:Infectious Disease, Pulmonary
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:March 7, 2007
End Date:March 28, 2013

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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.

The purpose of this study is to compare the efficacy and safety of isavuconazole versus
voriconazole in the treatment of patients with invasive aspergillosis.

Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous
fungi remain life threatening diseases. Early treatment with highly effective anti-fungals
reduces mortality. This study investigates the efficacy and safety of isavuconazole in the
treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

Inclusion Criteria:

- Patients must have proven, probable or possible invasive fungal disease caused by
Aspergillus species or other filamentous fungi

- Female patients must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

- Patients with invasive fungal infections other than Aspergillus species or other
filamentous fungi

- Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction

- Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary
aspergillosis

- Patients who have received more than 4 days of systemic antifungal therapy other than
fluconazole within the 7 days prior to the first administration of study medication

- Patients previously enrolled in a Phase III study with isavuconazole

- Patients with a body weight
We found this trial at
12
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Birmingham, Alabama 35294
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Buenos Aires,
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Chicago, IL
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46280
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Indianapolis, IN
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Lima, OH
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San Francisco, California 94143
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Springfield, Illinois 62701
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Springfield, IL
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Springfield, Illinois 62703
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Springfield, IL
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Worcester, MA
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