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

Severe COVID-19 Clinical Trial

— CoVAPid2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256511
• Other study ID #: HLJ_2022_01
• Status: Recruiting
• Start date: November 15, 2021
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: Saad NSEIR, MD,PhD
• Phone: 0320445962
• Email: Saadalla.NSEIR[@]CHRU-LILLE.FR
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1136
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Severe COVID-19

Locations

Country	Name	City	State
France	Hop Salengro - Hopital B Chr Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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