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

Covid-19 Clinical Trial

— FAP-REA  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04453540
• Other study ID #: 2020PI101
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: August 30, 2020

Study information

• Verified date: June 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Stewardship
• Communicable Diseases
• Covid-19
• Infection
• Infectious Disease
• Molecular Diagnosis
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Reims University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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