FDA关于抗菌药物治疗复杂性泌尿道感染与肾盂肾炎临床试验的考虑

FDA's considerations for anti-bacterial drugs clinical trials for treating complicated urinary tract infections and pyelonephritis

本文介绍了美国食品药品监督管理局(FDA)关于抗菌药物治疗复杂性泌尿道感染与肾盂肾炎临床试验的考虑。在开发药物以治疗这2种疾病时,应进行具有足够统计学意义和良好对照的试验,来确定其安全性和有效性,即其有效性较批准药物相似或更优效。这些研究中的主要有效性参数,应该是微生物学的检查结果,研究中应建立这些患者的临床治愈与细菌清除之间的总体相关性。

This article is to introduce FDA＇s （Food and Drug Admin- istration） considerations for anti - bacterial drugs clinical trials for treating complicated urinary tract infections and pyelonephritis. For developing drugs to treat these two diseases, a statistically adequate and well - controlled trial should be conducted establishing safety and effectiveness, similar or superior effectiveness to an approved product. The primary effectiveness parameter in these studies should be microbiological outcome. The study should establish the general correlation between clinical cure and bacterial eradication in these patients.