COVID-19 and VA-LRTI: Second Versus First Wave of the Pandemic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Severe COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Refusal to participate Lack of social security coverage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-CoV-2 first wave<br>Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the first wave of the pandemic, starting on 01-01-2020 | |
| SARS-CoV-2 second wave<br>Patients with confirmed SARS-CoV-2 infection and receiving invasive mechanical ventilation for more than 48h, in the second wave of the pandemic, starting on 10-01-2020 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis) |  | from day 3 of mechanical ventilation to extubation or day 28 post-intubation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, ventilator-associated tracheobronchitis, ventilator-associated pneumonia, bacterial co-infection, COVID-associated pulmonary aspergillosis