- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05256511
COVID-19 and VA-LRTI: Second Versus First Wave of the Pandemic (CoVAPid2)
May 20, 2026 updated by: University Hospital, Lille
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
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.
Study Overview
Status
Withdrawn
Conditions
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 Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lille, France, 59037
- Hop Salengro - Hopital B Chr Lille
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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SARS-CoV-2 first wave
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
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SARS-CoV-2 second wave
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Cumulative incidence of ventilator-associated lower respiratory tract infection (ventilator-associated pneumonia and ventilator associated tracheobronchitis)
Time Frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cumulative incidence of ventilator-associated tracheobronchitis
Time Frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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Cumulative incidence of ventilator-associated pneumonia
Time Frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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Prevalence of early bacterial coinfection
Time Frame: from day 0 to day 2 of mechanical ventilation
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from day 0 to day 2 of mechanical ventilation
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Cumulative incidence of COVID-associated pulmonary aspergillosis
Time Frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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from day 3 of mechanical ventilation to extubation or day 28 post-intubation
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ICU mortality
Time Frame: at day 28
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at day 28
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Mortality
Time Frame: at day 28
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at day 28
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Duration of mechanical ventilation (number of days under mechanical ventilation)
Time Frame: from the start of mechanical ventilation to extubation or day 28 after intubation
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from the start of mechanical ventilation to extubation or day 28 after intubation
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Duration of ICU stay (number of days in the ICU)
Time Frame: from the ICU admission to discharge or day 28 after admission
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from the ICU admission to discharge or day 28 after admission
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saad NSEIR, MD,PhD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2021
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
February 24, 2022
First Submitted That Met QC Criteria
February 24, 2022
First Posted (Actual)
February 25, 2022
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Healthcare-Associated Pneumonia
- Pathologic Processes
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- Cross Infection
- Iatrogenic Disease
- Pathological Conditions, Signs and Symptoms
- COVID-19
- Pneumonia, Ventilator-Associated
Other Study ID Numbers
- HLJ_2022_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.