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

NCT05076240 | Completed

• 1 other identifier: LOCAL/2021/LD-01
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV2 Infection; Ventilator Associated Pneumonia; Ards; COVID-19

Keywords

FilmARRAY; ARDS; COVID 19; ventilator associated pneumonia; DIAGNOSTIC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diagnostic Performance

  Day 7

• Bacterial ecology

  Day 7

• Fungal ecology

  Day 7

Study Arms (1)

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

Interventions

FilmArray® analysis PROCEDURE

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

Adults with ventilator associated pneumonia in COVID-19 ARDS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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®.

You may qualify if:

• Age ≥ 18 yers
• COVID-19 acute respiratory distress syndrome hospitalization
• affected Ventilator Associated Pneumonia
• having multiplex PCR analysis FilmArray®

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

COVID-19; Pneumonia, Ventilator-Associated; Acute Lung Injury; Disease

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; 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; Pathological Conditions, Signs and Symptoms; Lung Injury

Study Officials

• Claire ROGER, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 13, 2021
• Study Start: March 27, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)