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Completed

NCT Number: NCT04359693

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, ICU, CHU Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cumulative incidence of ventilator-associated lower respiratory tract infection

    Time frame: from day 3 of mechanical ventilation to extubation or day 28 post-intubation.

    the incidence of ventilator associated pneumonia and ventilator associated tracheobronchitis

Secondary outcomes

  1. Cumulative incidence of ventilator-associated tracheobronchitis

    Time frame: from day 3 of mechanical ventilation to extubation or day 28 post intubation

    incidence of ventilator-associated tracheobronchitis

  2. Cumulative incidence of ventilator-associated pneumonia

    Time frame: from Day 3 of mechanical ventilation to extubation or day 28 post intubation.

    incidence of ventilator-associated pneumonia

  3. the cumulative incidence of ICU acquired bacteremia diagnosed

    Time frame: from ICU admission to extubation or Day 28.

    incidence of ICU-acquired bacteremia

  4. ICU mortality

    Time frame: at day 28

    death in the ICU

  5. Mortality

    Time frame: at day 28

    death

  6. the duration of mechanical ventilation

    Time frame: from the start of mechanical ventilation to extubation or day 28 post intubation

    number of days Under mechanical ventilation

  7. Length of stay in Intensive Care Unit

    Time frame: from admission to ICU until extubation or Day 28

    number of days in the ICU

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Impact of SARS-CoV-2 Infection on the Incidence of Ventilator-acquired Infections

Acronym: COVAPID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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