[Translation] A single-arm, prospective, multicenter study evaluating the safety and efficacy of ISAVUCONAZOLE (isavuconazole) as the primary treatment regimen in Chinese patients with invasive mycosis caused by Aspergillus or other filamentous fungi
主要目的:通过观察经治疗出现的不良事件(TEAE) 来描述艾沙康唑的安全性和耐受性。
次要目的:描述艾沙康唑治疗曲霉菌属和其他丝状真菌引起的侵袭性真菌病(IFD) 中国患者的疗效。观察艾沙康唑的其他安全性和耐受性特征。评估艾沙康唑治疗曲霉菌属和其他丝状真菌引起的IFD 中国人群的药代动力学。
[Translation] Primary objective: To characterize the safety and tolerability of isavuconazole by observation of treatment-emergent adverse events (TEAEs).
Secondary objective: To describe the efficacy of isavuconazole in Chinese patients with invasive fungal disease (IFD) caused by Aspergillus and other filamentous fungi. Additional safety and tolerability profiles of isavuconazole were observed. To evaluate the pharmacokinetics of isavuconazole in the Chinese population with IFD caused by Aspergillus and other filamentous fungi.