Rezafungin治疗与caspofungin candidaemia和侵袭性念珠菌病(恢复):一个多中心、双盲、double-dummy,随机三期试验。
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汤普森GR 3日索里亚诺,科恩OA, Kullberg BJ, Kollef M,巴斯克斯J,欧诺瑞点,Bassetti M,普尔曼J, Chayakulkeeree M, Poromanski我Dignani C, Das房颤,Sandison T,帕帕斯PG
Rezafungin治疗与caspofungin candidaemia和侵袭性念珠菌病(恢复):一个多中心、双盲、double-dummy,随机三期试验。
柳叶刀》。2023年1月7日,401 (10370):49-59。doi: 10.1016 / s0140 - 6736 (22) 02324 - 8。Epub 2022年11月25日。
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36442484 (在PubMed]
- 文摘
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背景:Rezafungin下一代,一周一次echinocandin发展candidaemia和侵袭性念珠菌病的治疗和预防侵袭性念珠菌引起的真菌疾病,曲霉属真菌,血液和骨髓移植后肺孢子菌spp。我们旨在比较静脉注射的疗效和安全性rezafungin与患者静脉caspofungin candidaemia和侵袭性念珠菌病。方法:恢复是一个多中心、双盲、double-dummy,随机三期试验在15个国家的66个三级保健中心。成人(> / = 18年)与系统性的candidaemia迹象和真菌学的确认或侵袭性念珠菌病有资格入选,随机分配(1:1)接受静脉注射rezafungin一周一次(在周1 400毫克,紧随其后的是每周200毫克,总共两到四剂)或静脉caspofungin(70毫克负荷剂量1天,其次是每天50毫克)不超过4周。主端点是全球治疗(包括临床治疗、放射治疗和真菌学的根除)14天为欧洲医疗机构(EMA)和30天的全因死亡率为美国食品和药物管理局(FDA),这两个目标non-inferiority利润率为20%,评估修改意向处理人口(所有的病人接受一个或多个剂量的研究药物和记录念珠菌感染通常基于文化从血液或另一个无菌网站获得前96小时内随机)。安全评估的不良事件和死亡的发生率和类型安全的人口,定义为所有的病人接受任何数量的研究药物。审判是注册ClinicalTrials.gov NCT03667690,就完成了。发现:在10月12日,2018年,8月29日,2021年,222名患者筛查包容,和199名患者(118(59%)人;81名(41%)妇女;平均年龄61年[SD 15.2])被随机分配(100名(50%)患者rezafungin组,99名(50%)患者caspofungin集团)。 55 (59%) of 93 patients in the rezafungin group and 57 (61%) of 94 patients in the caspofungin group had a global cure at day 14 (weighted treatment difference -1.1% [95% CI -14.9 to 12.7]; EMA primary endpoint). 22 (24%) of 93 patients in the rezafungin group and 20 (21%) of 94 patients in the caspofungin group died or had an unknown survival status at day 30 (treatment difference 2.4% [95% CI -9.7 to 14.4]; FDA primary endpoint). In the safety analysis, 89 (91%) of 98 patients in the rezafungin group and 83 (85%) of 98 patients in the caspofungin group had at least one treatment-emergent adverse event. The most common treatment-emergent adverse events that occurred in at least 5% of patients in either group were pyrexia, hypokalaemia, pneumonia, septic shock, and anaemia. 55 (56%) patients in the rezafungin group and 52 (53%) patients in the caspofungin group had serious adverse events. INTERPRETATION: Our data show that rezafungin was non-inferior to caspofungin for the primary endpoints of day-14 global cure (EMA) and 30-day all-cause mortality (FDA). Efficacy in the initial days of treatment warrants evaluation. There were no concerning trends in treatment-emergent or serious adverse events. These phase 3 results show the efficacy and safety of rezafungin and support its ongoing development. FUNDING: Cidara Therapeutics and Mundipharma.
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