Status:
COMPLETED
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Basilea Pharmaceutica International Ltd
Conditions:
Aspergillosis
Invasive Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
- 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 \</= 40 kg
Key Trial Info
Start Date :
March 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2013
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00412893
Start Date
March 7 2007
End Date
March 28 2013
Last Update
December 10 2024
Active Locations (107)
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1
University of Alabama
Birmingham, Alabama, United States, 35294-0006
2
University of California at San Francisco
San Francisco, California, United States, 94143
3
University of Chicago, Division of Infectious Diseases
Chicago, Illinois, United States, 60637
4
Indiana BMT
Springfield, Illinois, United States, 62703