NCT00106288

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

A Multicenter, Double Blind, Comparative, Randomized Study to Evaluate the Efficacy and Safety of Micafungin (FK463) Versus Liposomal Amphotericin B (AmBisome) in the Treatment of Invasive Candidiasis and Candidemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.

Detailed description

A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned.

Conditions

• Candidiasis

Interventions

Type	Name	Description
DRUG	Micafungin	IV
DRUG	Liposomal Amphotericin B	IV

Timeline

• Start date: 2003-01-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-03-23
• Last updated: 2014-09-18

Locations

37 sites across 2 countries: United States, Canada