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

Impact of the FilmArray® Test on the 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.

Study Overview

• Status: Completed
• Conditions: COVID-19; SARS-CoV2 Infection; Ventilator Associated Pneumonia; Ards
• Intervention / Treatment: Procedure: FilmArray® analysis

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nîmes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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®.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: COVID 19; ARDS; ventilator associated pneumonia; FilmARRAY; DIAGNOSTIC
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; COVID-19; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: LOCAL/2021/LD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No