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



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

For Condition: Mycoses
Status: No longer recruiting
Sponsor(s): Fujisawa Healthcare, Inc. ,
Synopsis: 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.
Details: This will be a randomized, double-blind, comparative, parallel group study. Enrollment will include at least 600 patients in the U.S. and Canada.
Eligibility:
Study Type:  Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 600

Location and Contact Information:


Additional Information:
Study ID Numbers:  01-0-124; 
Study Start Date: October 2002
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048750

Other Mycoses Studies:
1. Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections

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

3. Voriconazole to Prevent Systemic Fungal Infections in Children

4. Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections

5. An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections

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