IV ITRACONAZOLE VS AMPHOTERICIN B IN BLASTOMYCOSIS OR HISTOPLASMOSIS

本研究的主要目的是评估IV伊曲康唑与标准治疗（两性霉素B）相比的安全性。 本研究还将评估IV诱导治疗结束时（7-14天）和PO巩固治疗后第2、12和24周的临床、微生物学和总体治疗应答。患者将随机接受伊曲康唑IV初始治疗，每天两次，持续2天（负荷剂量），然后每天一次，持续5天，或阿替霉素B IV治疗7天。 如果临床情况需要，允许延长治疗。静脉治疗后将进行伊曲康唑胶囊巩固治疗，每日一次，每日两次，最长持续一年。在诱导治疗期间（7-14天），伊曲康唑静脉输注1小时。 根据治疗的副作用，IV两性霉素B在1-6小时内输注。 在巩固治疗期间，口服伊曲康唑每天一次或每天两次，持续长达1年。

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.