FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context

• Conditions: Infectious Disease; Molecular Diagnosis; Pneumonia; Covid-19; Antibiotic Stewardship

• Registration Number: NCT04453540
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease.

During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods.

In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study Start: 2020-07-01
• Study First Posted: 2020-07-01
• Last Update Posted: 2020-07-01
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients > 18 years affiliated to a social security system
• Patients who have received complete information about the research and who have not objected to the use of its data
• Patients with suspected SARS-Cov-2 infection
• Patients for which a FilmArray test has been realized on its respiratory samples between 1st of March and 1st of July 2020.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic decision	24 h following the FilmArray results	Antibiotic prescription modification following the FilmArray results as: * No prescription; * No change in antibiotic utilization; * Antibiotic initiation; * Antibiotic escalation; * Antibiotic de-escalation; * Antibiotic discontinuation