Ventilation Associated Pneumonia and Covid-19 (ECOLCOVID)

Ventilator-associated Pneumonia Ecology Comparison in a French ICU Center NIMES Between First and Second Wave of COVID-19 : a Retrospective Monocentric Descriptive Study

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV2 Infection; Ventilator Associated Pneumonia; Ards

• Study Type: Observational
• Enrollment (Actual): 268

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients over 18 years old with a SARS-CoV-2 infection confirmed by positive PCR tests of nasopharyngeal or respiratory secretion samples. In addition, patients included presented a healthcare associated pneumonia according to SFAR(French Society of Anesthesia and Intensive Care) recommendations and based on criteria adapted from the European Centre for Disease Prevention and Control (ECDC) recommendations. Patients who refused their data use were excluded.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAP ecological difference between the first and second waves of COVID	Proportion of patients admitted to critical care with documented multidrug-resistant bacteria (MDR) VAP in Covid-19 wave 1 and 2	January 2020 to January 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of fungal co-infections	Comparison of the proportion of patients with a fungal infection during the 1st and 2nd wave	January 2020 to January 2021
duration of mechanical ventilation	Number of days under mechanical ventilations	Day 28
number of days of organ failure	number of days between first organ failure and no organ failure (discharge from intensive care)	Day 28
Mortality	proportion of patients deceased at day 28	Day 28
proportion of patients treated with corticosteroid therapy	proportion of patients treated with corticosteroid therapy	Day 28
probabilistic antibiotic therapy at admission	probabilistic antibiotic therapy prescribed at admission	Day 1
antiviral treatment	proportion of patients treated with antiviral treatment	Day 28

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): January 8, 2021
• Study Completion (Actual): January 8, 2021

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: ventilator associated pneumonia; SARS-CoV2 Infection; multidrug resistance; Intensive care Unit; COVID 19 ARDS
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; COVID-19; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: LOCAL/2021/LC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No