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

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04453540
• Collaborator: Reims University Hospital (Other)
• Enrollment: 150
• Anticipated Duration (Months): 2

Study Details

Study Description

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	Phase
Infectious Disease; Pneumonia; Molecular Diagnosis; Covid-19; Antibiotic Stewardship	Diagnostic Test: FilmArray PCR on respiratory samples

Study Design

• Study Type: Observational
• Anticipated 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.
• Anticipated Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Aug 30, 2020
• Anticipated Study Completion Date: Aug 30, 2020

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Central Hospital, Nancy, France
• Reims University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT04453540
• Other Study ID Numbers: 2020PI101
• First Posted: Jul 1, 2020
• Last Update Posted: Jul 1, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Pneumonia; Communicable Diseases; Infections

Study Results

No Results Posted as of Jul 1, 2020