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An alternative joint industry effort will provide information on combination versus single agent therapy for treatment of aspergillosis
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To evaluate the therapeutic effectiveness of voriconazole + micafungin versus voriconazole alone as primary therapy for invasive aspergillosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micafungin | Drug | |||
| voriconazole | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be Global Success (complete and partial response) at 6 weeks based on the combination of clinical, mycological and radiologic response. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Success (GS) at Wk 12, Favorable response (FR) & survival at Wks 6 & 12. GS and FR by infection site, overall frequency of emergent & recurrent fungal infections at Wks 6 & 12, duration of FR, and relationship of galactomannan to clinical outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| Fountain Valley |
| California |
| United States |
| Los Angeles | California | United States |
| Palo Alto | California | United States |
| Sacramento | California | United States |
| San Francisco | California | United States |
| Denver | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Miami | Florida | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Beech Grove | Indiana | United States |
| Indianapolis | Indiana | United States |
| Kansas City | Kansas | United States |
| Wichita | Kansas | United States |
| Lexington | Kentucky | United States |
| Baltimore | Maryland | United States |
| Bethesda | Maryland | United States |
| Boston | Massachusetts | United States |
| Charlestown | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Detroit | Michigan | United States |
| Grand Rapids | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Rochester | Minnesota | United States |
| Omaha | Nebraska | United States |
| Albany | New York | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Portland | Oregon | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Charlottesville | Virginia | United States |
| Fairfax | Virginia | United States |
| Richmond | Virginia | United States |
| Madison | Wisconsin | United States |
| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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