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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:
6565405
负责人:
Peter George Pappas
金额:
$17.53万
依托单位国家:
美国
项目类别:
财政年份:
2001
资助国家:
美国
项目状态:
已结题
起止时间:
2001-12-01 至 2002-11-30

项目摘要

项目成果

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中文摘要
翻译
本研究的主要目的是评估静脉注射的安全性 伊曲康唑与标准护理(两性霉素B)的比较。这项研究 还将评估临床、微生物和总体反应 静脉诱导治疗结束(7-14天)和PO后的治疗 在第2、12、24周进行巩固治疗。 患者将随机接受静脉注射的初始治疗 伊曲康唑,每天两次,连续两天(负荷量),然后每天一次 再服用5天或两性霉素-B静脉注射7天。扩展 如果患者的临床情况需要,将允许进行治疗 它。静脉注射治疗后将进行巩固治疗, 伊曲康唑胶囊每天一次或一天两次,疗程长达一年。 在诱导治疗期间(7-14天),静脉滴注伊曲康唑超过 一小时时间段。静脉输注两性霉素-B超过1-6小时 治疗期间视患者的副作用而定。在.期间 巩固疗法口服伊曲康唑每日一次或 一天两次,最多一年。
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 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.
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