Impact of SARS-CoV-2 Infection on the Incidence of Ventilator-acquired Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,576
- 试验地点
- 2
- 主要终点
- Cumulative incidence of ventilator-associated lower respiratory tract infection
研究概览
简要总结
Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.
详细描述
COVAPID is a multicenter cohort study with two retrospective control groups. No intervention will be performed in included patients, only patient characteristics and data on VA-LRTI will be collected.
Patients with confirmed SARS-CoV-2 community-acquired pneumonia, admitted to the participating ICUs from the start of COVID epidemic will be eligible for this study. Those admitted before the beginning of this study will be included retrospectively, and those admitted after the beginning of the study will be included prospectively. 10-20 patients per center will be included in this group. SARSCoV2 infection will be confirmed by a nasopharyngeal PCR or respiratory secretions (tracheal aspirate or bronchoalveolar lavage) PCR. Two retrospective groups will be constituted in order to give some insight of potential impact of SARS-CoV2 infection on the incidence of VALRTI :1) Influenza group : patients with influenza (A or B) community-acquired pneumonia. All patients with influenza community acquired pneumonia and admitted in the same ICU will be eligible in this group.
The number of patients included in this group per center will be similar as that of patients included in the SARS-CoV-2 pneumonia group (10-20 patients). These consecutive patients will by identified using the files of Virology Lab. The first included patient will be the last of the current influenza season (2019-2020), and others will be taken consecutively back to 2019 of 2018 if necessary. PCR (nasopharyngeal or respiratory secretions) confirmation of influenza (A ou B) is required for patients in this group. 2) No viral infection group: patients with no viral community acquired pneumonia. All patients receiving invasive mechanical ventilation for more than 48h before COVID epidemic, for any reason other than viral pneumonia are eligible for this group. The number of included patients in this group will be similar as that of patients included in the SARS-CoV-2 group in the same center (10-20 patients) These consecutive patients will be included starting at the end of January 2020 and going back to 2019 if necessary. 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
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all three groups:
- •Major patient
- •In patients in ICU
- •Patients intubated and mechanically ventilated for more than 48 hours.
- •For the SARS-CoV2 group: community-acquired SARS-CoV2 pneumonia For the influenza group: community-acquired influenza pneumonia For the "No Viral Infection" group: no viral pneumonia on admission.
排除标准
- •Refusal to participate
- •Lack of social security coverage
研究组 & 干预措施
SARS-CoV2 group
Patients receiving invasive mechanical ventilation for more than 48h with SARS-CoV-2 infection
Flu group
Patients receiving invasive mechanical ventilation for more than 48h with influenza infection
No viral infection group
Patients receiving invasive mechanical ventilation for more than 48h with no viral infection at ICU admission
结局指标
主要结局
Cumulative incidence of ventilator-associated lower respiratory tract infection
时间窗: from day 3 of mechanical ventilation to extubation or day 28 post-intubation.
the incidence of ventilator associated pneumonia and ventilator associated tracheobronchitis
次要结局
- Cumulative incidence of ventilator-associated pneumonia(from Day 3 of mechanical ventilation to extubation or day 28 post intubation.)
- ICU mortality(at day 28)
- Length of stay in Intensive Care Unit(from admission to ICU until extubation or Day 28)
- Cumulative incidence of ventilator-associated tracheobronchitis(from day 3 of mechanical ventilation to extubation or day 28 post intubation)
- the cumulative incidence of ICU acquired bacteremia diagnosed(from ICU admission to extubation or Day 28.)
- Mortality(at day 28)
- the duration of mechanical ventilation(from the start of mechanical ventilation to extubation or day 28 post intubation)