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临床试验/NCT04290780
NCT04290780已完成不适用

Multicenter Study on Nosocomial Transmission of SARS-CoV-2 Virus

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 2,162 人开始时间: 2020年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,162
试验地点
1
主要终点
nosocomial infection

研究概览

简要总结

Infection with the SARS-CoV-2 coronavirus strain is associated with severe morbidity and mortality estimated today from 2% to 4%. Elderly patients or patients with serious chronic conditions justifying hospitalization are particularly at risk. The risk of infection with SARS-CoV-2 during hospitalization is also substantial and increased in fragile patients. Several cases of infection among Healthcare Professionals had been reported.

The hypothesis is that similar to the corona virus agent responsible for SRAS and the influenza virus, nosocomial outbreaks of SARS-CoV-2 to be feared. Health care professionals and caregivers are populations-at-risk as they are exposed in the community and can transmit SARS-CoV-2 to hospitalized patients, and are also exposed to hospitalized patients infected with SARS-CoV-2.

Describing hospital-acquired cases and SARS-CoV-2 infection transmission chains in healthcare settings is vitally essential to achieve control of this epidemic. To improve the quality of care and patient safety, this data must be accompanied by an analysis of the impact of infection control measures. In addition, an effective infection control program is urgently required to control the spread of the virus and protect both uninfected patients who require care for other medical or surgical conditions as well as health care professionals.

The main objective of this prospective, non-interventional - observational, hospital based study in adults and children is to describe and document suspected or confirmed cases of nosocomial SARS-CoV-2 infection, the clinical spectrum and the determinants (risk factors/protective factors) at participating hospitals.

Characterization of the clinical features of the SARS-CoV-2 infection will help to identify potential sources of virus transmission as rapidly as possible and enable implementation of appropriate hygiene practices in hospitals.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 1 ) Any adult or child or member of the nursing staff from the study participant hospital who presents an infectious syndrome including the following definition :
  • 2) Suspect Case:
  • Fever above 37.8 ° C if no antipyretics are taken; And or Cough or pharyngeal pain or other symptom suggestive of respiratory infection. AND at least 1 of the following characteristics:
  • return from a trip to China, or to a country in which the increase in the incidence of infections in SARS-CoV-2 has been proven;
  • close contact (sharing the same place of family, professional life, same plane, etc.) with a person defined as a suspected or confirmed case;
  • Occurring in an establishment having received at least one case of suspected or confirmed infection at SARS-CoV-
  • Or 3) Confirmed Case: The same clinical definitions, in addition to a positive RT-PCR-type virological diagnostic result specific to SARS-CoV-2

排除标准

  • Anyone who does not meet the above definition.

结局指标

主要结局

nosocomial infection

时间窗: At inclusion

The primary outcome criteria will be the proportion of patients, caregivers and health care professionals with confirmed or suspected SARS-CoV-2 nosocomial infection relative to all patients, caregivers and health care professionals with syndromes suggestive of SARS-CoV-2 infection during the study period. The infection control measures will be reported and describe according the nosocomial cases.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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