Burden of Influenza at Emergency Department (ED) Level in European Countries

Influenza, Human Clinical Trial

Official title:

Burden of Influenza at Emergency Department (ED) Level in European Countries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04244500
• Other study ID #: UMR893958
• Status: Recruiting
• Start date: January 27, 2020
• Est. completion date: August 2020

Study information

• Verified date: January 2020
• Source: University of Rostock
• Contact: Martin Bienengraeber, Dr.
• Phone: +49 381 494 5031
• Email: dekanat.forschung[@]med.uni-rostock.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.

Description:

Study objectives

Primary:

• Measure the proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season

Secondary:

• Describe the demographic and medical profile of influenza-related and non-influenza-related visits

• Identify socio-demographic or other risk factors associated with ED visit outcome

• Describe the influenza positivity rate among ED visits for different causes

• Measure the proportion of influenza positive patients without classical ILI symptoms

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: August 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult patients seeking care at participating ED during the influenza season

• Participants and/or guardian providing informed consent and/or assent, as appropriate, to participate.

Exclusion Criteria:

• Individuals reporting having suffered a traumatic injury without other conditions.

Related Conditions & MeSH terms

• Emergencies
• Influenza, Human

Intervention

Procedure:
• swab sampling
Multiplex polymerase chain reaction assay for organisms of upper respiratory tract infections

Locations

Country	Name	City	State
Germany	University of Rostock	Rostock

Sponsors (4)

Lead Sponsor	Collaborator
University of Rostock	Klinikum Ernst von Bergmann Potsdam, Klinikum Suedstadt, Rostock, Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	influenza status at admission to ED (positive vs. negative)	proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season	at admission to ED
Secondary	demographic and medical profile	demographic and medical profile of influenza-related and non-influenza-related visits	at admission to ED
Secondary	socio-demographic or other risk factors	Identify socio-demographic or other risk factors associated with ED visit outcome	at admission to ED
Secondary	influenza without classical symptoms of influenza-like illness	Measure the proportion of influenza positive patients without classical ILI symptoms	at admission to ED