Clinical trial NCT05076240: FilmArray® and Management of Ventilator Associated Pneumonia in COVID-19 ARDS
Official title: Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV2 Infection
Ventilator Associated Pneumonia
Ards
COVID-19
Keywords: FilmARRAY
ARDS
COVID 19
ventilator associated pneumonia
DIAGNOSTIC
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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®.

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.


Eligibility 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

Primary outcomes:
measure: Impact of FilmArray® on the adaptation of antibiotic therapy
timeFrame: Day 7
Secondary outcomes:
measure: Diagnostic Performance
timeFrame: Day 7
measure: Bacterial ecology
timeFrame: Day 7
measure: Fungal ecology
timeFrame: Day 7
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Claire ROGER, MD, PhD
role: STUDY_DIRECTOR
References: