NCT00105144

Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

A Phase 3, Randomized, Double-Blind, Comparative Study of Micafungin (FK463) Versus Caspofungin as Antifungal Treatment in Patients With Invasive Candidiasis or Candidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 611 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and effectiveness of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia.

Detailed description

The purpose of the study is to determine the efficacy and safety of two dose levels of micafungin versus caspofungin in the treatment of proven invasive candidiasis or candidemia. The maximum length of antifungal treatment is 4 weeks except in pre-defined patients where maximum length of therapy is 8 weeks. A post treatment assessment will be conducted at 2 weeks and 6 weeks after the last dose of all antifungal treatments.

Conditions

• Candidiasis
• Candidemia

Interventions

Type	Name	Description
DRUG	Micafungin	IV
DRUG	Caspofungin	IV

Timeline

• Start date: 2004-09-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2005-03-08
• Last updated: 2014-09-18

Locations

167 sites across 15 countries: United States, Austria, Belgium, Brazil, Canada, Croatia, Czechia, France, Germany, India, Netherlands, Poland, Spain, Switzerland, United Kingdom