Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project.

Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project.
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DOI:
10.1136/bmjopen-2020-039088
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发表时间:
2020-10-22
期刊:
影响因子:
2.9
通讯作者:
Vanhems P
Vanhems P
中科院分区:
医学3区
文献类型:
--
作者:
Saadatian-Elahi M;Picot V;Hénaff L;Pradel FK;Escuret V;Dananché C;Elias C;Endtz HP;Vanhems P

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新发现的SARS-CoV-2可导致严重的急性呼吸道感染,如肺炎。在法国,一般人群的死亡率约为10%,在医院可能达到更高水平。在目前社区SARS-CoV-2发病率高的背景下,预计医院内传播率将显著增加。在医疗体系脆弱的低收入国家,医院传播的风险甚至可能更高。本方案旨在估计参与医院的疑似或确诊SARS-CoV-2医院感染病例的患病率和发生率、临床谱和决定因素(风险因素/保护因素)。这将是一项在成人和儿童中开展的国际多中心前瞻性、观察性、以医院为基础的研究。它将包括法国的志愿患者和医疗保健专业人员以及GABRIEL网络附属医院。人口统计学和临床数据将使用专门为项目目的设计的病例报告表收集。将采集鼻咽拭子并通过逆转录酶PCR检测SARS-CoV-2。将分析研究参与者的特征,确认的医院SARS-CoV-2感染相对于所有提示SARS-CoV-2感染的综合征患者的比例。将使用适当的多变量建模来确定与医院内发病相关的决定因素。本研究获得了所有参与国家的临床研究和委员会的批准。研究结果将提交给同行评审期刊发表,并与国家卫生当局分享。NCT 04290780。
The newly identified SARS-CoV-2 can cause serious acute respiratory infections such as pneumonia. In France, mortality rate in the general population was approximately 10% and could reach higher levels at the hospital. In the current context of high incidence rates of SARS-CoV-2 in the community, a significant increase in the rate of nosocomial transmission is expected. The risk of nosocomial transmission could even be higher in low-income countries that have fragile healthcare systems. This protocol is intended to estimate the prevalence and incidence of suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective) at participating hospitals. This will be an international multicentre prospective, observational, hospital-based study in adults and children. It will include volunteer patients and healthcare professionals in France and hospitals affiliated with the GABRIEL network. Demographic and clinical data will be collected using case report forms designed especially for the purpose of the project. A nasopharyngeal swab will be collected and tested for SARS-CoV-2 by reverse-transcriptase PCR. Characteristics of the study participants, the proportion of confirmed nosocomial SARS-CoV-2 infections relative to all patients with syndromes suggestive of SARS-CoV-2 infection, will be analysed. Appropriate multivariate modelling will be used to identify the determinants associated with nosocomial onset. This study was approved by the clinical research and committee of all participating countries. The findings will be submitted to peer-reviewed journal for publication and shared with national health authorities. NCT04290780.
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