FDA“医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎：供企业用治疗药物开发指导原则”介绍

美国食品药品监督管理局（FDA）于2020年6月发布了“医院获得性细菌性肺炎和呼吸机相关性细菌性肺炎：供企业用治疗药物开发指导原则”。该指导原则阐述了治疗这类疾病的抗菌药物临床研究的一般原则和具体试验设计的建议。介绍该指导原则的主要内容，期待对中国“医院获得性细菌性肺炎/呼吸机相关细菌性肺炎抗菌药物临床试验技术指导原则（征求意见稿）”的定稿和促进这类药物的研究有帮助。

Introduction of FDA Hospital-Acquired Bacterial Pneumonia and VentilatorAssociated Bacterial Pneumonia: Developing Drugs for Treatment Guidance for Industry

FDA issued Hospital-Acquired Bacterial Pneumonia and VentilatorAssociated Bacterial Pneumonia:Developing Drugs for Treatment Guidance for Industry in June 2020. The guidance describes the general principles of clinical trials of antimicrobials for the treatment of these diseases and the recommendations for specific trial design. The guidance is introduced in detail. It is expected to contribute to the finalization of Technical guidelines for clinical trials of antimicrobials in hospital acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (Draft) and promoting the research of these drugs in China.