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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05076240
Recruitment Status : Completed
First Posted : October 13, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

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

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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of 18 years old and more, hospitalized in intensive care between 27th March 2020 and April 2021 for COVID-19 acute respiratory distress syndrome, declaring a Ventilator Associated Pneumonia diagnosed by culture and having multiplex PCR analysis FilmArray®.
Criteria

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


Information from the National Library of Medicine

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


Locations
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France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Claire ROGER, MD, PhD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT05076240    
Other Study ID Numbers: LOCAL/2021/LD-01
First Posted: October 13, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
FilmARRAY
ARDS
COVID 19
ventilator associated pneumonia
DIAGNOSTIC
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Pneumonia, Ventilator-Associated
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Healthcare-Associated Pneumonia
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes