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

COVID-19 Clinical Trial

— COVIDARRAY  

Official title:

Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05076240
• Other study ID #: LOCAL/2021/LD-01
• Status: Completed
• Start date: March 27, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ards
• COVID-19
• Pneumonia
• Pneumonia, Ventilator-Associated
• SARS-CoV2 Infection
• Ventilator Associated Pneumonia

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Bacterial ecology	Description of the bacterial species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19	Day 7
Secondary	Fungal ecology	Description of the fungal species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19	Day 7