FilmArray® and Management of Ventilator Associated Pneumonia in COVID-19 ARDS

Study Overview
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Brief Summary
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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.

Official Title
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Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS

Conditions
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SARS-CoV2 Infection, Ventilator Associated Pneumonia, Ards, COVID-19

Intervention / Treatment
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* Procedure: FilmArray® analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 yers COVID-19 acute respiratory distress syndrome hospitalization affected Ventilator Associated Pneumonia having multiplex PCR analysis FilmArray® Exclusion Criteria : Patient opposition to participate to the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults with ventilator associated pneumonia in COVID-19 ARDS<br>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<br>* FilmArray® multiplex PCR analysis to diagnose ventilator associated pneumonia in COVID-19 ARDS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of FilmArray® on the adaptation of antibiotic therapy | Proportion of patients for whom the FilmArray® technique induces an adaptation of antibiotic therapy | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance | Diagnostic performance of FilmArray® in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID 19 (evaluated by FilmArray®-culture diagnostic concordance | Day 7 | 
| Bacterial ecology | Description of the bacterial species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19 | Day 7 | 
| Fungal ecology | Description of the fungal species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19 | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FilmARRAY, ARDS, COVID 19, ventilator associated pneumonia, DIAGNOSTIC