NCT00413218

Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Detailed description

Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are randomized to isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.

Conditions

• Candidiasis, Invasive
• Candidemia
• Mycoses

Interventions

Type	Name	Description
DRUG	Isavuconazole	Administered by intravenous infusion.
DRUG	Caspofungin	Administered by intravenous infusion.
DRUG	Voriconazole	Administered by intravenous infusion.

Timeline

• Start date: 2007-03-08
• Primary completion: 2015-03-03
• Completion: 2015-03-03
• First posted: 2006-12-19
• Last updated: 2024-12-10
• Results posted: 2017-08-01

Locations

113 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Hungary, India, Israel, Italy, Lebanon, Malaysia, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa, Spain, Switzerland, Thailand