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| ID | Type | Description | Link |
|---|---|---|---|
| 98-0-046 | Other Identifier | Alternate Protocol Number |
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The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.
This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FK463 | Drug |
Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Univ.-Klinik | Graz | 8036 | Austria | |||
| Krankenhaus Elisabethinen Linz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16678903 | Result | Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. doi: 10.1016/j.jinf.2006.03.003. Epub 2006 May 6. | |
| 18983417 |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results website | View source |
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| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| 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 |
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| Linz |
| A-4010 |
| Austria |
| Hopital Henri Mondor, Service d'Hematologie Clinique | Créteil | 94010 | France |
| Hotel Dieu, Service d'Hematologie | Nantes | 44093 | France |
| Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle | Paris | 10 | France |
| Hopital Necker Enfants Malades, Service d'Hematologie | Paris | 75015 | France |
| Johann Wolfgang Goethe Universitat, Medizinische Klinik III | Frankfurt | D-60590 | Germany |
| Westpfalz Krankehaus | Kaiserslautern | D-67655 | Germany |
| Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie | Leipzig | D-04103 | Germany |
| Klinikum der Stadt, Medizinische Klinik A | Ludwigshafen | D-67063 | Germany |
| Uniklinik Mainz | Mainz | 55101 | Germany |
| LMU Munchen, Hamatopoetische Zell - Transplantation | München | D-81366 | Germany |
| Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie | Würzburg | E-97070 | Germany |
| Nationale Institute for Cancer Research | Genova | I 16132 | Italy |
| Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera | Milan | 20162 | Italy |
| Institute of Haematology and Blood Transfusion | Warsaw | 00-957 | Poland |
| Hospital Clinic I provencial, Servicio Enfermadades Infecciosas | Barcelona | ES 28041 | Spain |
| Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas | Madrid | ES 28007 | Spain |
| Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas | Madrid | ES 28041 | Spain |
| Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology | Huddinge | SE141 86 | Sweden |
| Royal Free Hospital, Dept. of Haematological Oncology | London | NW3 2QG | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital | Sutton Surrey | SM2 5PT | United Kingdom |
| Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdiere M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8. |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |