NCT00634049

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

Detailed description

Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the safety and efficacy of isavuconazole in participants with aspergillosis and renal impairment, and in participants suffering from invasive infections from rare fungi.

Conditions

• Aspergillosis
• Invasive Fungal Infections

Interventions

Type	Name	Description
DRUG	isavuconazole	Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral

Timeline

• Start date: 2008-04-22
• Primary completion: 2014-01-03
• Completion: 2016-05-05
• First posted: 2008-03-12
• Last updated: 2024-12-11
• Results posted: 2016-01-11

Locations

96 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Egypt, France, Germany, India, Israel, Lebanon, Mexico, Poland, Russia, South Africa, South Korea, Thailand