IV ITRACONAZOLE VS AMPHOTERICIN B IN BLASTOMYCOSIS OR HISTOPLASMOSIS

两性霉素B一直是治疗严重真菌感染的标准药物。 感染，但治疗往往受到其肾毒性的限制。 的 第一项研究是开发静脉注射伊曲康唑， 耐受性和安全性，并描述动力学。 无不良 四名志愿者报告了他们的经历。 静脉注射伊曲康唑 然后给重症监护室的病人服用口服溶液 单位和恶性血液病患者。 这些研究揭示 每天两次口服溶液的患者倾向于有更高的 IV给药结束时的谷水平，但患者 仅接受每日一次口服给药， 更低的水平。伊曲康唑胶囊被批准用于 治疗芽生菌病和组织胞浆菌病，并可作为第一 线治疗的患者有轻度至中度形式的这些疾病。 用于重症患者的巩固治疗 经过一个短疗程的静脉注射青蒿素B后 对于患者， 严重的疾病或那些无法服用口服胶囊，IV形式的 伊曲康唑，提供可靠的血药浓度水平， 毒性比阿霉素-B少的患者将非常 有利于 本研究的主要目的是评估 IV伊曲康唑与标准治疗相比的安全性 （阿替霉素-B）。 该研究还将评估临床， 微生物学和IV结束时的总体治疗应答 诱导治疗和PO巩固治疗后。

Amphotericin B has been the standard of care for serious fungal infections, but treatment is often limited by its nephrotoxicity. The first study in the develoment of IV itraconazole was to assess the tolerability and safety and to describe the kinetics. No adverse experiences were reported by the four volunteers. IV itraconazole was then given followed by oral solution to patients in the intensive care unit and patients with hematologic malignancies. These studies revealed that patients receiving oral solution twice daily tended to have higher trough levels than those at the conclusion of IV dosing, but patients receiving only once daily oral dosing tended to have similar or somewhat lower trough levels. Itraconazole capsules are approved for the treatment of blastomycosis and histoplasmosis and can be used as first line therapy for patients with mild to moderate forms of these diseases. It is used as a consolidation therapy for patients with severe disease after a short course of IV amphotericin-B. For patients with more severe disease or those unable to take oral capsules, an IV form of itraconazole that provides reliable blood concentration levels in ill patients with fewer toxicities than amphotericin-B would be very beneficial. The primary purpose of the current 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 and after PO consolidation therapy.