Back to resultsBurden of Influenza at Emergency Department Level : BIED (BIED)
Primary Purpose
Emergencies, Flu
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasal swab
Sponsored by
About this trial
This is an interventional other trial for Emergencies
Eligibility Criteria
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
Sites / Locations
- Service Hygiène, Epidémiologie et Prévention
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients admitted to emergency department with medical cause
Arm Description
Patient included in emergency with a nasal swab
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04153331
Brief Title
Burden of Influenza at Emergency Department Level : BIED
Acronym
BIED
Official Title
Burden of Influenza at Emergency Department Level : BIED
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies, Flu
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2487 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients admitted to emergency department with medical cause
Arm Type
Experimental
Arm Description
Patient included in emergency with a nasal swab
Intervention Type
Other
Intervention Name(s)
Nasal swab
Intervention Description
Patient included in emergency with a nasal swab
Primary Outcome Measure Information:
Title
Proportion of laboratory confirmed influenza among patients admitted to Emergency Room during the influenza season
Description
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
Time Frame
1 day (at admission)
Secondary Outcome Measure Information:
Title
Proportion of patients with co-morbidities
Description
to evaluate the proportion of patients consulting emergency department who have co-morbidities according to the result of the virological sampling
Time Frame
1 day (at admission)
Title
Proportion of patients with laboratory confirmed influenza and related outcomes
Description
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
Time Frame
1 day (at admission)
Title
Proportion of patients who consult for other causes than influenza
Description
to estimate the proportion of patients with a laboratory confirmed influenza consulting for other causes than influenza
Time Frame
1 day (at admission)
Title
Proportion of asymptomatic influenza cases among patients with laboratory confirmed influenza
Description
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
Time Frame
1 day (at admission)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philppe VANHEMS, MD
Organizational Affiliation
Service Hygiène, Epidémiologie et Prévention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service Hygiène, Epidémiologie et Prévention
City
Lyon
ZIP/Postal Code
69003
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Burden of Influenza at Emergency Department Level : BIED
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