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

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT05076240
Collaborator
(none)
98
Enrollment
1
Location
1.1
Actual Duration (Months)
87.7
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Procedure: FilmArray® analysis

Study Design

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 :
Mar 27, 2021
Actual Primary Completion Date :
Apr 30, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Impact of FilmArray® on the adaptation of antibiotic therapy [Day 7]

    Proportion of patients for whom the FilmArray® technique induces an adaptation of antibiotic therapy

Secondary Outcome Measures

  1. Diagnostic Performance [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 [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 [Day 7]

    Description of the fungal species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CHU de Nîmes - Hôpital Universitaire CarémeauNîmes Cedex 09France30029

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

  • Study Director: Claire ROGER, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT05076240
Other Study ID Numbers:
  • LOCAL/2021/LD-01
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021