Ventilation Associated Pneumonia and Covid-19

NCT05089968 | Completed

• 1 other identifier: LOCAL/2021/LC-01
• Study Type: observational
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection; Ventilator Associated Pneumonia; Ards; COVID-19

Keywords

Intensive care Unit; multidrug resistance; COVID 19 ARDS; ventilator associated pneumonia; SARS-CoV2 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• proportion of fungal co-infections

  January 2020 to January 2021

• duration of mechanical ventilation

  Day 28

• number of days of organ failure

  Day 28

• Mortality

  Day 28

• proportion of patients treated with corticosteroid therapy

  Day 28

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 18 years
• Positive SARS-Cov-2 polymerase chain reaction (PCR)
• healthcare associated pneumonia

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

COVID-19; Pneumonia, Ventilator-Associated; Acute Lung Injury

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury

Study Officials

• Claire ROGER, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: October 22, 2021
• Study Start: January 24, 2020
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)