Impact of COVID-19 Infection on the Incidence of Ventilator-acquired Infections

Completed

• Conditions: SARS-CoV 2

• Registration Number: NCT04359693
• Lead Sponsor: University Hospital, Lille

Brief Summary

Observational cohort study aiming at comparing the incidence of ventilator-associated lower respiratory tract infections between COVID-19 patients and two control groups: one with influenza pneumonia and the other with no viral pneumonia.

Detailed Description

COVAPID is a multicenter cohort study with two retrospective control groups. No intervention will be performed in included patients, only patient characteristics and data on VA-LRTI will be collected.

Patients with confirmed SARS-CoV-2 community-acquired pneumonia, admitted to the participating ICUs from the start of COVID epidemic will be eligible for this study. Those admitted before the beginning of this study will be included retrospectively, and those admitted after the beginning of the study will be included prospectively. 10-20 patients per center will be included in this group. SARSCoV2 infection will be confirmed by a nasopharyngeal PCR or respiratory secretions (tracheal aspirate or bronchoalveolar lavage) PCR. Two retrospective groups will be constituted in order to give some insight of potential impact of SARS-CoV2 infection on the incidence of VALRTI :1) Influenza group : patients with influenza (A or B) community-acquired pneumonia. All patients with influenza community acquired pneumonia and admitted in the same ICU will be eligible in this group.

The number of patients included in this group per center will be similar as that of patients included in the SARS-CoV-2 pneumonia group (10-20 patients). These consecutive patients will by identified using the files of Virology Lab. The first included patient will be the last of the current influenza season (2019-2020), and others will be taken consecutively back to 2019 of 2018 if necessary. PCR (nasopharyngeal or respiratory secretions) confirmation of influenza (A ou B) is required for patients in this group. 2) No viral infection group: patients with no viral community acquired pneumonia. All patients receiving invasive mechanical ventilation for more than 48h before COVID epidemic, for any reason other than viral pneumonia are eligible for this group. The number of included patients in this group will be similar as that of patients included in the SARS-CoV-2 group in the same center (10-20 patients) These consecutive patients will be included starting at the end of January 2020 and going back to 2019 if necessary. VAT and VAP are defined using clinical, radiological and quantitative microbiological criteria.

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Study Start: 2020-04-22
• Study First Posted: 2020-04-24
• Status Verified: 2020-07
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1576

Inclusion Criteria

For all three groups:

• Major patient
• In patients in ICU
• Patients intubated and mechanically ventilated for more than 48 hours.

For the SARS-CoV2 group: community-acquired SARS-CoV2 pneumonia For the influenza group: community-acquired influenza pneumonia For the "No Viral Infection" group: no viral pneumonia on admission.

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	from day 3 of mechanical ventilation to extubation or day 28 post-intubation.	the incidence of ventilator associated pneumonia and ventilator associated tracheobronchitis

Secondary Outcome Measures

Name	Time	Method
the cumulative incidence of ICU acquired bacteremia diagnosed	from ICU admission to extubation or Day 28.	incidence of ICU-acquired bacteremia
Mortality	at day 28	death
the duration of mechanical ventilation	from the start of mechanical ventilation to extubation or day 28 post intubation	number of days Under mechanical ventilation
Cumulative incidence of ventilator-associated pneumonia	from Day 3 of mechanical ventilation to extubation or day 28 post intubation.	incidence of ventilator-associated pneumonia
ICU mortality	at day 28	death in the ICU
Length of stay in Intensive Care Unit	from admission to ICU until extubation or Day 28	number of days in the ICU
Cumulative incidence of ventilator-associated tracheobronchitis	from day 3 of mechanical ventilation to extubation or day 28 post intubation	incidence of ventilator-associated tracheobronchitis

Trial Locations

Locations (1)

Hôpital Roger Salengro, ICU, CHU Lille; 🇫🇷 Lille, France