Clinical trial NCT05256511: COVID-19 and VA-LRTI: Second Versus First Wave of the Pandemic
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe COVID-19
Keywords: SARS-CoV-2
ventilator-associated tracheobronchitis
ventilator-associated pneumonia
bacterial co-infection
COVID-associated pulmonary aspergillosis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 1136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis)
timeFrame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
Secondary outcomes:
measure: Cumulative incidence of ventilator-associated tracheobronchitis
timeFrame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
measure: Cumulative incidence of ventilator-associated pneumonia
timeFrame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
measure: Prevalence of early bacterial coinfection
timeFrame: from day 0 to day 2 of mechanical ventilation
measure: Cumulative incidence of COVID-associated pulmonary aspergillosis
timeFrame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
measure: ICU mortality
timeFrame: at day 28
measure: Mortality
timeFrame: at day 28
measure: Duration of mechanical ventilation (number of days under mechanical ventilation)
timeFrame: from the start of mechanical ventilation to extubation or day 28 after intubation
measure: Duration of ICU stay (number of days in the ICU)
timeFrame: from the ICU admission to discharge or day 28 after admission
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Salengro - Hopital B Chr Lille
Study officials:
affiliation: University Hospital, Lille
name: Saad NSEIR, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: