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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:
6303025
负责人:
Peter George Pappas
金额:
$2.95万
依托单位国家:
美国
项目类别:
财政年份:
1999
资助国家:
美国
项目状态:
已结题
起止时间:
1999-12-01 至 2000-11-30

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中文摘要
翻译
这项研究的主要目的是评估静脉注射伊曲康唑的安全性,并与治疗标准(两性霉素B)进行比较。这项研究还将评估静脉诱导治疗结束(7-14天)和PO巩固治疗后2、12和24周的临床、微生物学和总体反应。患者将被随机分成两组,一组接受伊曲康唑静脉注射,每日两次,持续两天(负荷量),后一组,每日一次,持续5天,或两性霉素-B静脉注射,持续7天。在延长治疗之后,将使用伊曲康唑胶囊进行巩固治疗,每天一次或每天两次,最长可达一年。在诱导治疗期间(7-14天),静脉滴注伊曲康唑超过1小时。静脉注射两性霉素-B的时间为1-6小时。巩固疗法同上。
英文摘要
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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