Laboratoire des Pathogènes Emergents, Fondation Mérieux, Centre International de Recherche en Infectiologie (CIRI), INSERM U1111, CNRS, Lyon, France.
Service Hygiène, Epidémiologie et Prévention, Centre Hospitalier Edouard Herriot, Hospices Civils de Lyon, Lyon, France.
BMJ Open. 2020 Oct 22;10(10):e039088. doi: 10.1136/bmjopen-2020-039088.
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.
新发现的严重急性呼吸系统综合征冠状病毒 2 型（SARS-CoV-2）可引起严重的急性呼吸道感染，如肺炎。在法国，普通人群的死亡率约为 10%，在医院可能会更高。在当前社区 SARS-CoV-2 发病率高的情况下，预计医院内的传播率会显著增加。在医疗体系脆弱的低收入国家，医院内传播的风险甚至可能更高。本方案旨在估计参与医院中疑似或确诊的 SARS-CoV-2 医院感染、临床谱和决定因素（危险因素/保护因素）的患病率和发病率。
这将是一项在法国和与 GABRIEL 网络有关联的医院中进行的针对成人和儿童的国际多中心前瞻性、观察性、基于医院的研究。它将包括志愿者患者和医护人员。将使用专门为该项目设计的病例报告表收集人口统计学和临床数据。将采集鼻咽拭子并通过逆转录酶聚合酶链反应（RT-PCR）检测 SARS-CoV-2。将对研究参与者的特征、相对于所有具有 SARS-CoV-2 感染综合征提示的患者，确诊的 SARS-CoV-2 医院感染的比例进行分析。将使用适当的多变量模型来确定与医院内发病相关的决定因素。
这项研究得到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，并与国家卫生当局共享。
NCT04290780。
