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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05089968
Other study ID # LOCAL/2021/LC-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 24, 2020
Est. completion date January 8, 2021

Study information

Verified date October 2021
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date January 8, 2021
Est. primary completion date January 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
France CHU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 09

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary duration of mechanical ventilation Number of days under mechanical ventilations Day 28
Secondary number of days of organ failure number of days between first organ failure and no organ failure (discharge from intensive care) Day 28
Secondary Mortality proportion of patients deceased at day 28 Day 28
Secondary proportion of patients treated with corticosteroid therapy proportion of patients treated with corticosteroid therapy Day 28
Secondary probabilistic antibiotic therapy at admission probabilistic antibiotic therapy prescribed at admission Day 1
Secondary antiviral treatment proportion of patients treated with antiviral treatment Day 28
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