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FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context (FAP-REA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04453540
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Reims University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Infectious Disease Pneumonia Molecular Diagnosis Covid-19 Antibiotic Stewardship Diagnostic Test: FilmArray PCR on respiratory samples

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Intervention Details:
  • Diagnostic Test: FilmArray PCR on respiratory samples
    Molecular test performed on respiratory samples realized for microbiological routine testing as part of the care

Primary Outcome Measures :
  1. Therapeutic decision [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed in ICU at the hospitals of Nancy and Reims for severe respiratory diseases during the first half of 2020

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
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Responsible Party: Central Hospital, Nancy, France Identifier: NCT04453540    
Other Study ID Numbers: 2020PI101
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections