IV ITRACONAZOLE VS AMPHOTERICIN B IN BLASTOMYCOSIS OR HISTOPLASMOSIS

$29,529M01FY2000RRNIH

University Of Alabama At Birmingham, Birmingham AL

Investigators

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Abstract

The primary purpose of this study is to assess the safety of IV intraconazole compared to the standard of care (Amphotericin B). The study will also assess the clinical, microbiological, and overall response to therapy at the end of IV induction therapy (7-14 days) and after PO consolidation therapy at 2,12, and 24 weeks. Patients will be randomized to either an initial treatment with IV intraconazole twice daily for 2 days (loading dose) and then once daily for 5 additional days or amphotericin-B by IV for 7 days. Extended treatment will be followed by consolidation therapy with itraconazole capsules once daily or twice daily for up to 1 year. During induction therapy (7-14 days) IV intraconazole is infused over a 1-hour period. IV Amphotericin-B is infused over a 1-6 hour period. Consolidation therapy is the same as above.

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