Clinical Trial: Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Center, Open, Parallel, Comparative, Randomized Study of Micafungin (FK463) vs Fluconazole (Diflucan) in the Treatment of Invasive Candidiasis and Candidaemia (Pr

Brief Summary: To determine the efficacy and safety of micafungin (FK463) versus fluconazole (Diflucan) in treating patients with invasive candidiasis or candidaemia

Detailed Summary: Micafungin (a new class of antifungal drugs) is compared to fluconazole (current standard treatment) in the treatment of patients with serious fungal infections (invasive candidiasis and candidemia) to determine its efficacy and safety. Patients, both male and female, aged over 16 and with confirmed disease by the doctor could be recruited and evaluated.
Sponsor: Astellas Pharma Inc

Current Primary Outcome: Response rate [ Time Frame: 2-8 Weeks ]

Original Primary Outcome:

Current Secondary Outcome: Clinical response, mycological response [ Time Frame: 2-8 weeks ]

Original Secondary Outcome:

Information By: Astellas Pharma Inc

Dates:
Date Received: September 12, 2005
Date Started: August 2004
Date Completion:
Last Updated: December 26, 2007
Last Verified: December 2007