Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Completed · Phase 3

Conditions studied: Aspergillosis, Invasive Fungal Infection

In brief

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

Key facts

Study ID

NCT00412893

Run by

Astellas Pharma Inc

People needed

527

Starts

2007-03-07

Expected to finish

2013-03-28

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California at San Francisco — San Francisco, California, United States
• University of Chicago, Division of Infectious Diseases — Chicago, Illinois, United States
• Indiana BMT — Springfield, Illinois, United States
• Springfield Clinic LLP — Springfield, Illinois, United States
• Infectious Disease of Indiana — Indianapolis, Indiana, United States
• Brigham & Womens Hospital — Boston, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Upstate Infectious Diseases Association LLP — Albany, New York, United States
• Regional Infection Diseases Infusion Center Inc. — Lima, Ohio, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Capital Federal, Argentina
• Study site — Capital Federal, Argentina
• Hospital Italiano de Buenos Aires — Ciudad Autonoma, Argentina
• Instituto Medico Especializado Alexander Fleming — Ciudad Autonoma, Argentina
• Study site — Perth, Australia
• Mater Medical Centre — South Brisbane, Australia
• Study site — Woolloongabba, Australia
• AZ ST Jan — Bruges, Belgium
• Institut Jules Bordet — Brussels, Belgium
• ULB Hospital Erasme — Brussels, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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