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

• Conditions: Severe COVID-19

• Registration Number: NCT05256511
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2021-11-15
• Status Verified: 2022-02
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-02-25
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-06
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1136

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
ICU mortality	at day 28
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
Cumulative incidence of COVID-associated pulmonary aspergillosis	from day 3 of mechanical ventilation to extubation or day 28 post-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 ventilator-associated pneumonia	from day 3 of mechanical ventilation to extubation or day 28 post-intubation
Duration of ICU stay (number of days in the ICU)	from the ICU admission to discharge or day 28 after admission

Trial Locations

Locations (1)

Hop Salengro - Hopital B Chr Lille; 🇫🇷 Lille, France