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

NCT ID: NCT05076240

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

98 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-27

Study Completion Date

2021-04-30

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.

Detailed Description

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Conditions

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SARS-CoV2 Infection Ventilator Associated Pneumonia Ards COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

FilmArray® analysis

Intervention Type PROCEDURE

FilmArray® multiplex PCR analysis to diagnose ventilator associated pneumonia in COVID-19 ARDS

Interventions

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FilmArray® analysis

FilmArray® multiplex PCR analysis to diagnose ventilator associated pneumonia in COVID-19 ARDS

Intervention Type PROCEDURE

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®
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire ROGER, MD, PhD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2021/LD-01

Identifier Type: -

Identifier Source: org_study_id