Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU

• Status: Terminated
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of intravenous micafungin versus placebo as prophylactic therapy for invasive fungal infections in patients in the intensive care unit considered to be at high risk.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Antifungal Agents; Echinocandins; Micafungin; Miconazole

Criteria

Inclusion Criteria

• Meets entry criteria for high risk

Exclusion Criteria

• Evidence of active invasive fungal infection

• Received more than one dose of systemic antifungal agent within 72 hours prior to first dose of study drug

• Known to be HIV positive who have CD4 count less than 500 cells/mm3

• Has life-expectancy of less than 72 hours or moribund