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

NCT ID: NCT04453540

Last Updated: 2020-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2020-08-30

Brief Summary

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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

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Conditions

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Infectious Disease Pneumonia Molecular Diagnosis Covid-19 Antibiotic Stewardship

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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FilmArray PCR on respiratory samples

Molecular test performed on respiratory samples realized for microbiological routine testing as part of the care

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reims University hospital

OTHER

Sponsor Role collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Novy E, Goury A, Thivilier C, Guillard T, Alauzet C. Algorithm for rational use of Film Array Pneumonia Panel in bacterial coinfections of critically ill ventilated COVID-19 patients. Diagn Microbiol Infect Dis. 2021 Nov;101(3):115507. doi: 10.1016/j.diagmicrobio.2021.115507. Epub 2021 Jul 23.

Reference Type DERIVED
PMID: 34364096 (View on PubMed)

Other Identifiers

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2020PI101

Identifier Type: -

Identifier Source: org_study_id

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