FilmArray® and Management of Ventilator Associated Pneumonia in COVID-19 ARDS (COVIDARRAY)
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|ClinicalTrials.gov Identifier: NCT05076240|
Recruitment Status : Completed
First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%.
VAPs complicate about 40-50% of COVID-19 acute respiratory distress syndrome (ARDS) and the mortality would be twice higher.
Thus, in this context of the COVID-19 pandemic, this represents a considerable rate of patients.
Unfortunately, the risk factors for VAPs are poorly understood and the bacterial ecology varies around the world. Also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care.
New microbiological rapid diagnostic techniques have appeared in recent years, among them the FilmArray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics.
This technique has been studied in acute community pneumonia but has not been validated in VAP and even less during the COVID-19 period.
Investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using FilmArray® would improve the relevance of the antibiotic treatment.
The aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of Ventilator Associated Pneumonia during COVID-19 acute respiratory distress syndrome before an interventional study.
|Condition or disease||Intervention/treatment|
|SARS-CoV2 Infection Ventilator Associated Pneumonia Ards COVID-19||Procedure: FilmArray® analysis|
|Study Type :||Observational|
|Actual Enrollment :||98 participants|
|Official Title:||Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS|
|Actual Study Start Date :||March 27, 2021|
|Actual Primary Completion Date :||April 30, 2021|
|Actual Study Completion Date :||April 30, 2021|
Adults with ventilator associated pneumonia in COVID-19 ARDS
Patient hospitalized in intensive care unit for acute respiratory distress related to a Sars-Cov2 infection having contracted ventilator associated pneumonia. The diagnosis was made by culture but also with a FilmArray® multiplex PCR analysis.
Procedure: FilmArray® analysis
FilmArray® multiplex PCR analysis to diagnose ventilator associated pneumonia in COVID-19 ARDS
- Impact of FilmArray® on the adaptation of antibiotic therapy [ Time Frame: Day 7 ]Proportion of patients for whom the FilmArray® technique induces an adaptation of antibiotic therapy
- Diagnostic Performance [ Time Frame: Day 7 ]Diagnostic performance of FilmArray® in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID 19 (evaluated by FilmArray®-culture diagnostic concordance
- Bacterial ecology [ Time Frame: Day 7 ]Description of the bacterial species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19
- Fungal ecology [ Time Frame: Day 7 ]Description of the fungal species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076240
|CHU de Nîmes - Hôpital Universitaire Carémeau|
|Nîmes Cedex 09, France, 30029|
|Study Director:||Claire ROGER, MD, PhD||Centre Hospitalier Universitaire de Nîmes|