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Doripenem for treating nosocomial pneumonia and ventilator-associated pneumonia - Authors' reply.
The Lancet Infectious Diseases ( IF 36.4 ) Pub Date : 2020-01-01 , DOI: 10.1016/s1473-3099(19)30717-0
Marin H Kollef 1 , Álvaro Réa-Neto 2 , Richard G Wunderink 3 , Christopher J Bruno 4 , Elizabeth G Rhee 4
Affiliation  

We thank Hung-Jen Tang and Chih-Cheng Lai for their interest in our Article. Contemporary non-inferiority clinical trials of hospital-acquired pneumonia and ventilator-associated pneumonia assess two main efficacy endpoints: 28 day all-cause mortality and clinical response after the end of therapy. Although regulatory agencies differ in their preferred primary endpoint, it is crucial that results for all-cause mortality and clinical response are supportive of each other when evaluating new therapies for hospital-acquired and ventilator-associated pneumonia.

中文翻译:

多利培南用于治疗医院内肺炎和呼吸机相关性肺炎-作者的回复。

感谢唐洪仁和赖志成对我们的文章的关注。医院获得性肺炎和呼吸机相关性肺炎的当代非劣效性临床试验评估了两个主要功效终点:28天全因死亡率和治疗结束后的临床反应。尽管监管机构在首选的主要终点指标方面存在差异,但至关重要的是,在评估医院获得性和呼吸机相关性肺炎的新疗法时,全因死亡率和临床反应的结果必须相互支持。
更新日期:2019-12-25
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