IV ITRACONAZOLE VS AMPHOTERICIN B IN BLASTOMYCOSIS OR HISTOPLASMOSIS

University Of Alabama At Birmingham, Birmingham AL

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Abstract

The primary purpose of this study is to assess the safety of IV itraconazole 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 itraconazole twice a day for two days (loading dose) and then once a day for five additional days or amphotericin-B IV for seven days. Extended treatment would be allowed if the patient's clinical condition required it. IV treatment will be followed by consolidation therapy with itraconazole capsules once daily or twice a day for up to one year. During induction therapy (7-14 days) IV itraconazole is infused over a one-hour period of time. IV Amphotericin-B is infused over a 1-6 hour period of time depending on the patient's side effects to therapy. During consolidation therapy oral itraconazole is given either once a day or twice a day for up to one year.