ECOLCOVID: Ventilation Associated Pneumonia and Covid-19

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT05089968
Collaborator
(none)
268
1
11.5
23.3

Study Details

Study Description

Brief Summary

In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Since the beginning of the pandemic, Standard of care have evolved with new data. The prevalence of these VAPs seems significantly higher in the population of patients with ARDS COVID-19 (40-50%) and their ecology seems to have evolved over time, particularly in terms of bacterial resistance. Investigators want to describe and compare this evolution of bacterial and fungal ecology as well as identify potential risk factors that may be associated with these changes in ecology during different waves.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    268 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Ventilator-associated Pneumonia Ecology Comparison in a French ICU Center NIMES Between First and Second Wave of COVID-19 : a Retrospective Monocentric Descriptive Study
    Actual Study Start Date :
    Jan 24, 2020
    Actual Primary Completion Date :
    Jan 8, 2021
    Actual Study Completion Date :
    Jan 8, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Patient from the first wave of COVID-19

    57 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 1st wave from January 24, 2020 to July 10, 2020

    Patient from the Second wave of COVID-19

    211 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 2nd wave from July 11, 2020 to January 8, 2021

    Outcome Measures

    Primary Outcome Measures

    1. VAP ecological difference between the first and second waves of COVID [January 2020 to January 2021]

      Proportion of patients admitted to critical care with documented multidrug-resistant bacteria (MDR) VAP in Covid-19 wave 1 and 2

    Secondary Outcome Measures

    1. proportion of fungal co-infections [January 2020 to January 2021]

      Comparison of the proportion of patients with a fungal infection during the 1st and 2nd wave

    2. duration of mechanical ventilation [Day 28]

      Number of days under mechanical ventilations

    3. number of days of organ failure [Day 28]

      number of days between first organ failure and no organ failure (discharge from intensive care)

    4. Mortality [Day 28]

      proportion of patients deceased at day 28

    5. proportion of patients treated with corticosteroid therapy [Day 28]

      proportion of patients treated with corticosteroid therapy

    6. probabilistic antibiotic therapy at admission [Day 1]

      probabilistic antibiotic therapy prescribed at admission

    7. antiviral treatment [Day 28]

      proportion of patients treated with antiviral treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age > 18 years

    • Positive SARS-Cov-2 polymerase chain reaction (PCR)

    • healthcare associated pneumonia

    Exclusion Criteria : Patient opposition to participate to the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09 France 30029

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Nīmes

    Investigators

    • Principal Investigator: Claire ROGER, MD, PhD, Centre Hospitalier Universitaire de Nîmes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Nīmes
    ClinicalTrials.gov Identifier:
    NCT05089968
    Other Study ID Numbers:
    • LOCAL/2021/LC-01
    First Posted:
    Oct 22, 2021
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire de Nīmes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 22, 2021