Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Taiwan, Inc.
• Treatments: Echinocandins; Fluconazole; Micafungin

Criteria

Inclusion Criteria:

• Patients with a confirmed diagnosis of candidemia and invasive candidiasis

• Patients could be newly diagnosed with candidiasis who received no more than 48 hours of prior systemic antifungal therapy

• Inpatients aged 16 and above

Exclusion Criteria:

• Patients with serious invasive candidiasis whose prognoses are considered to be poor (life expectancy judged to be less than 5 days).

• Patients with severe complications in the liver

• Pregnant or lactating women

• Patients who have received at least 5 days of prior systemic treatment of fluconazole or echinocandin with no response.

• Patients who have prior antifungal infection requiring treatment with systemic antifungal agents for conditions other than candidemia and invasive candidiasis.