NCT04153331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,487

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
Last Updated

September 4, 2025

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

November 4, 2019

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Proportion of patients with co-morbidities

    1 day (at admission)

  • Proportion of patients with laboratory confirmed influenza and related outcomes

    1 day (at admission)

  • Proportion of patients who consult for other causes than influenza

    1 day (at admission)

  • Proportion of asymptomatic influenza cases among patients with laboratory confirmed influenza

    1 day (at admission)

Study Arms (1)

Patients admitted to emergency department with medical cause

EXPERIMENTAL

Patient included in emergency with a nasal swab

Other: Nasal swab

Interventions

Patient included in emergency with a nasal swab

Patients admitted to emergency department with medical cause

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Consultation for a medical cause

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Hygiène, Epidémiologie et Prévention

Lyon, 69003, France

Location

Related Publications (1)

  • Amour S, Rubio AP, Orsi A, Oppert M, Loebermann M, Del Pozo Vegas C, Tazarourte K, Douplat M, Jacquin L, Icardi G, Walker J, Glass A, Nealon J, Chaves SS; FERS Study Group; Bricout H, Vanhems P. Influenza in Adults Seeking Care at Seven European Emergency Departments: A Prospective Active Surveillance During the 2019-2020 Influenza Season. Influenza Other Respir Viruses. 2024 Nov;18(11):e70040. doi: 10.1111/irv.70040.

MeSH Terms

Conditions

EmergenciesInfluenza, Human

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Philppe VANHEMS, MD

    Service Hygiène, Epidémiologie et Prévention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 6, 2019

Study Start

January 13, 2020

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

September 4, 2025

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations