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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00008840 |
The purpose of this study is to evaluate the safety and effectiveness of 2 drugs (AmBisome versus voriconazole) in treating fungal infections. Immunocompromised patients, especially those with persistent fever and neutropenia, are at a high risk of developing deeply invasive, life-threatening fungal infections with Candida, Aspergillus, and other opportunistic fungal pathogens. The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever. Antifungal therapy, therefore, is an important step in the amelioration of fungal disease.
Condition |
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Neutropenia |
Study Type: | Observational |
Study Design: | Natural History |
Official Title: | A Randomized, Open Label, Comparative, Multicenter Trial of Voriconazole Vs. AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia |
Estimated Enrollment: | 866 |
Estimated Study Completion Date: | November 2005 |
Patients are first split into groups to receive either voriconazole or AmBisome. Both drugs are given through a vein (IV) for at least 3 days. At the conclusion of 3 days, the voriconazole patients are then switched to oral voriconazole. The AmBisome patients continue with IV AmBisome. Both groups continue treatment until blood counts increase and fever subsides.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
You may be eligible for this study if you:
Exclusion Criteria:
You will not be eligible for this study if you:
Study ID Numbers: | DMID MSG 42, 150-603 |
Study First Received: | January 18, 2001 |
Last Updated: | November 9, 2006 |
ClinicalTrials.gov Identifier: | NCT00008840 |
Health Authority: | United States: Federal Government |
Abelcet Amphotericin B Hematologic Diseases Clotrimazole Miconazole Agranulocytosis Tioconazole |
Leukocyte Disorders Liposomal amphotericin B Granulocytopenia Fever Neutropenia Voriconazole Leukopenia |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Pharmacologic Actions |