Burden of Influenza at Emergency Department Level : BIED (BIED)

Seasonal influenza surveillance in France relies on several sources to detect the onset of the epidemic early, as well as to estimate the severity of epidemics and their impact on the health system. However, the data collected do not fully measure the impact of epidemics on the hospital system.

Increasing the investigator's knowledge of the impact of influenza on the hospital system, particularly on emergencies, which are the most affected service, is essential to better adapt the resources put in place to care for patients.

The study will allow a better understanding of the influenza burden, by systematically documenting the severe events (i.e. requiring consultations to the Emergency Rooms) that are triggered by influenza but not necessarily reported/recorded as influenza.

Study Overview

• Status: Completed
• Conditions: Emergencies; Flu
• Intervention / Treatment: Other: Nasal swab

• Study Type: Interventional
• Enrollment (Actual): 2487
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Service Hygiène, Epidémiologie et Prévention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 18 years
• Consultation for a medical cause

Exclusion Criteria:

• Consultation for a non-medical cause (trauma...)
• Pregnant, parturient and lactating women
• Persons deprived of their liberty
• Persons of full age who are subject to a legal protection measure
• Persons not affiliated to a social security system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients admitted to emergency department with medical cause; Patient included in emergency with a nasal swab	Other: Nasal swab; Patient included in emergency with a nasal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of laboratory confirmed influenza among patients admitted to Emergency Room during the influenza season	The proportion of laboratory confirmed influenza cases will be calculated by dividing the number of patients with laboratory confirmed influenza by the total number of patients included	1 day (at admission)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with co-morbidities	to evaluate the proportion of patients consulting emergency department who have co-morbidities according to the result of the virological sampling	1 day (at admission)
Proportion of patients with laboratory confirmed influenza and related outcomes	to estimate the proportion of patients with a laboratory confirmed influenza stratified on the emergency department visit outcomes (hospitalization in medicine, hospitalization in intensive care unit or return home) and other covariates	1 day (at admission)
Proportion of patients who consult for other causes than influenza	to estimate the proportion of patients with a laboratory confirmed influenza consulting for other causes than influenza	1 day (at admission)
Proportion of asymptomatic influenza cases among patients with laboratory confirmed influenza	The proportion asymptomatic influenza cases will be calculated by dividing the number of patients with asymptomatic influenza by the total number of laboratory confirmed influenza	1 day (at admission)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Philppe VANHEMS, MD, Service Hygiène, Epidémiologie et Prévention

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): March 9, 2020
• Study Completion (Actual): March 9, 2020

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 69HCL19_0755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No