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

Completed

• Conditions: Ventilator Associated Pneumonia; COVID-19; SARS-CoV2 Infection; Ards
• Interventions: Procedure: FilmArray® analysis

• Registration Number: NCT05076240
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-27
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-10
• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-13
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with ventilator associated pneumonia in COVID-19 ARDS	FilmArray® analysis	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Bacterial ecology	Day 7	Description of the bacterial species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19
Fungal ecology	Day 7	Description of the fungal species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France