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.
18 Years
N/A
Both
Invasive Fungal Infection, Aspergillosis
Trial Information
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.
Inclusion Criteria:
- Patients must have probable or proven 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
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
All-cause mortality through Day 42
Outcome Time Frame:
Up to Day 42
Safety Issue:
No
Principal Investigator
Medical Director
Investigator Role:
Study Director
Investigator Affiliation:
Astellas Pharma Global Development
Authority:
United States: Food and Drug Administration
Study ID:
9766-CL-0104
NCT ID:
NCT00412893
Start Date:
December 2006
Completion Date:
March 2013
Related Keywords:
- Invasive Fungal Infection
- Aspergillosis
- Phase III
- Invasive fungal disease
- Aspergillus species
- Filamentous fungi
- ASP9766
- BAL8557
- Isavuconazole
- Aspergillosis
- Mycoses
Name | Location |
|---|---|
| University of Alabama | Birmingham, Alabama |
| Infectious Disease of Indiana | Indianapolis, Indiana 46218 |
| Boston, Massachusetts | |
| 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 |
