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

NCT04453540 | Unknown DMC

• 1 other identifier: 2020PI101
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infectious Disease; Pneumonia; Molecular Diagnosis; Covid-19; Antibiotic Stewardship

Outcome Measures

Primary Outcomes (1)

• Therapeutic decision

  Antibiotic prescription modification following the FilmArray results as: * No prescription * No change in antibiotic utilization * Antibiotic initiation * Antibiotic escalation * Antibiotic de-escalation * Antibiotic discontinuation

  24 h following the FilmArray results

Interventions

FilmArray PCR on respiratory samples DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Reims University hospital: collaborator

Related Publications (1)

• 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.

  PMID: 34364096 DERIVED

MeSH Terms

Conditions

Communicable Diseases; Pneumonia; COVID-19

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 1, 2020
• Study Start: July 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: July 1, 2020

Record last verified: 2020-06