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Inadequate enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the incidence of a proven or probable invasive fungal infection, catheter tip fungal infection, or deep incisional surgical site infection during the study | Baseline through one week post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the incidence of patients requiring alternative systemic antifungal therapy to treat suspected infection | Baseline through one week post-treatment |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
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| Placebo |
| Drug |
IV |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Los Angeles | California | 90033 | United States |
| Los Angeles | California | 90048 | United States |
| Oakland | California | 94609 | United States |
| Orange | California | 92868 | United States |
| Sacramento | California | 95817 | United States |
| San Francisco | California | 94110 | United States |
| Santa Barbara | California | 93102 | United States |
| Stanford | California | 94304 | United States |
| Stanford | California | 94305 | United States |
| Denver | Colorado | 80262 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Tampa | Florida | 33601 | United States |
| Atlanta | Georgia | 30303 | United States |
| Maywood | Illinois | 60153 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Indianapolis | Indiana | 46260 | United States |
| Indianapolis | Indiana | 46390 | United States |
| Portland | Maine | 04102 | United States |
| Baltimore | Maryland | 21201 | United States |
| Baltimore | Maryland | 21287 | United States |
| Boston | Massachusetts | 02114 | United States |
| Detroit | Michigan | 48201 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| St Louis | Missouri | 63110 | United States |
| Omaha | Nebraska | 68198 | United States |
| Newark | New Jersey | 07103 | United States |
| Rochester | New York | 14642 | United States |
| Durham | North Carolina | 27110 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Nashville | Tennessee | 37212 | United States |
| Dallas | Texas | 75246 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Charlottesville | Virginia | 22906 | United States |
| Seattle | Washington | 98104 | United States |
| Hamilton | Ontario | L8V 1C3 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Regina | Saskatchewan | S4P 0W5 | Canada |
| Saskatoon | Saskatchewan | S7N0W8 | Canada |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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