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Completed

NCT Number: NCT05076240

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

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.

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Key information

Conditions

SARS-CoV2 Infection ARDS Acute Lung Injury COVID-19 Coronaviridae Infections Coronavirus Infections Cross Infection Disease Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Lung Injury Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FilmArray® analysis

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: COVIDARRAY

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 13, 2021
Registry last updated
Oct 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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