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IV ITRACONAZOLE VS AMPHOTERICIN B IN BLASTOMYCOSIS OR HISTOPLASMOSIS

IV ITRACONAZOLE VS AMPHOTERICIN B IN BLASTOMYCOSIS OR HISTOPLASMOSIS
IV 伊曲康唑与两性霉素 B 在芽生菌病或组织胞浆菌病中的比较
批准号：
6112840
负责人：
Peter George Pappas
金额：
$2.95万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6112840
关键词：
amphotericin B blastomycosis clinical research drug screening /evaluation histoplasmosis human subject human therapy evaluation intravenous administration itraconazole microorganism disease chemotherapy

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英文摘要
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 2 days (loading dose) and then once a day for 5 additional days or amphotericin-B IV for 7 days. Extended treatment would be allowed if the clinical condition required it. IV treatment will be followed by consolidation therapy with itraconazole capsules once daily for 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 side effects to therapy. During consolidation therapy oral itraconazole is given either once a day or twice a day for up to 1 year.
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