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临床试验/NCT05256511
NCT05256511撤回不适用

Incidence of Ventilator-associated Lower Respiratory Tract Infections Among Patients With SARS-CoV-2 Infection Throughout the First and the Second Wave of the Pandemic: a European Comparative Cohort Study

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 1,136 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
1,136
试验地点
2
主要终点
Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis)

研究概览

简要总结

Multicenter observational retrospective cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic.

详细描述

CoVAPid2 is a multicenter retrospective observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients from the first and the second wave of the pandemic. Patients with confirmed SARS-CoV-2 community-acquired pneumonia and receiving invasive mechanical ventilation for more than 48h in the participating ICUs from the start of COVID pandemic are eligible for this study. Consecutive patients will be included from the beginning of the first wave (starting on 01-01-2020, data already collected in the CoVAPid1 study) and the second wave (starting on 10-01-2020). 10-20 patients per wave will be included in each center. VAT and VAP are defined using clinical, radiological and quantitative microbiological criteria.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major (18 years and older)
  • Admitted to the ICU
  • Intubated and mechanically ventilated for more than 48 hours
  • With a confirmed community-acquired SARS-CoV2 pneumonia

排除标准

  • Refusal to participate
  • Lack of social security coverage

结局指标

主要结局

Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis)

时间窗: from day 3 of mechanical ventilation to extubation or day 28 post-intubation

次要结局

  • Prevalence of early bacterial coinfection(from day 0 to day 2 of mechanical ventilation)
  • Duration of mechanical ventilation (number of days under mechanical ventilation)(from the start of mechanical ventilation to extubation or day 28 after intubation)
  • Mortality(at day 28)
  • Cumulative incidence of ventilator-associated tracheobronchitis(from day 3 of mechanical ventilation to extubation or day 28 post-intubation)
  • Cumulative incidence of COVID-associated pulmonary aspergillosis(from day 3 of mechanical ventilation to extubation or day 28 post-intubation)
  • Cumulative incidence of ventilator-associated pneumonia(from day 3 of mechanical ventilation to extubation or day 28 post-intubation)
  • ICU mortality(at day 28)
  • Duration of ICU stay (number of days in the ICU)(from the ICU admission to discharge or day 28 after admission)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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