NCT00412893

Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 527 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.

Conditions

• Aspergillosis
• Invasive Fungal Infection

Interventions

Type	Name	Description
DRUG	Isavuconazole	Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).
DRUG	Voriconazole	Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

Timeline

• Start date: 2007-03-07
• Primary completion: 2013-03-28
• Completion: 2013-03-28
• First posted: 2006-12-19
• Last updated: 2024-12-10
• Results posted: 2015-03-31

Locations

107 sites across 26 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Egypt, France, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Poland, Russia, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye)