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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00048750 |
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.
Condition | Intervention | Phase |
---|---|---|
Invasive Fungal Infections |
Drug: Micafungin Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized,Double-Blind, Comparative Study of Micafungin (FK463) Versus Placebo as Preemptive Prophylactic Antifungal Therapy in Patients in the Intensive Care Unit |
Enrollment: | 104 |
Study Start Date: | January 2003 |
Study Completion Date: | June 2003 |
Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Micafungin
IV
|
2: Placebo Comparator |
Drug: Placebo
IV
|
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Study Director: | Central Contact | Astellas Pharma US, Inc. |
Responsible Party: | Astellas Pharma US, Inc. ( Sr Manager Clinical Trials Registry ) |
Study ID Numbers: | 01-0-124 |
Study First Received: | November 6, 2002 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00048750 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Anti-Fungal Therapy Preemptive Anti-Fungal Therapy Invasive Fungal Infection Micafungin ICU |
Mycoses Clotrimazole Miconazole Tioconazole Micafungin |
Anti-Infective Agents Anti-Infective Agents, Local Antifungal Agents |
Therapeutic Uses Infection Pharmacologic Actions |