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

January 26, 2020 updated by: Dr. med. Micha Loebermann, University of Rostock
This study plans to conduct enhanced influenza surveillance at a hospital emergency department level independent of underlying influenza-like symptoms.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18057
        • Recruiting
        • University of Rostock
        • Contact:
        • Principal Investigator:
          • Micha Loebermann, PD Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients seeking care at the emergency department of participating hospitals

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Influenza
Influenza testing
Procedure: swab sampling
Multiplex polymerase chain reaction assay for organisms of upper respiratory tract infections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
influenza status at admission to ED (positive vs. negative)
Time Frame: at admission to ED
proportion of non-traumatic emergency department (ED) visits infected with influenza during the peak of the influenza season
at admission to ED

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic and medical profile
Time Frame: at admission to ED
demographic and medical profile of influenza-related and non-influenza-related visits
at admission to ED
socio-demographic or other risk factors
Time Frame: at admission to ED
Identify socio-demographic or other risk factors associated with ED visit outcome
at admission to ED
influenza without classical symptoms of influenza-like illness
Time Frame: at admission to ED
Measure the proportion of influenza positive patients without classical ILI symptoms
at admission to ED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Collaborators

Sanofi Pasteur, a Sanofi Company
Klinikum Ernst von Bergmann Potsdam
Klinikum Suedstadt, Rostock

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2020

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

January 12, 2020

First Submitted That Met QC Criteria

January 26, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 26, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMR893958

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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