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| Sponsor: | Astellas Pharma Inc |
|---|---|
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00048750 |
Purpose
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
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Los Angeles, California, United States, 90048 | |
| Orange, California, United States, 92868 | |
| Oakland, California, United States, 94609 | |
| Los Angeles, California, United States, 90033 | |
| Sacramento, California, United States, 95817 | |
| San Francisco, California, United States, 94110 | |
| Santa Barbara, California, United States, 93102 | |
| Stanford, California, United States, 94305 | |
| Stanford, California, United States, 94304 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010 | |
| Washington D.C., District of Columbia, United States, 20010 | |
| United States, Florida | |
| Tampa, Florida, United States, 33601 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Illinois | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46202 | |
| Indianapolis, Indiana, United States, 46390 | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Maine | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27110 | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States, 17033 | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Dallas, Texas, United States, 75246 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Charlottesville, Virginia, United States, 22906 | |
| United States, Washington | |
| Seattle, Washington, United States, 98104 | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| London, Ontario, Canada, N6A 5A5 | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7N0W8 | |
| Regina, Saskatchewan, Canada, S4P 0W5 | |
| Study Director: | Central Contact | Astellas Pharma US, Inc. |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Anti-Fungal Therapy Preemptive Anti-Fungal Therapy Invasive Fungal Infection Micafungin ICU |
|
Anti-Infective Agents Mycoses Communicable Diseases Therapeutic Uses |
Antifungal Agents Infection Pharmacologic Actions Micafungin |
