NCT04244500

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 12, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

January 12, 2020

Last Update Submit

January 26, 2020

Conditions

Influenza, Human

Keywords

emergency roomepidemiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • demographic and medical profile

    at admission to ED

  • socio-demographic or other risk factors

    at admission to ED

  • influenza without classical symptoms of influenza-like illness

    at admission to ED

Study Arms (1)

Influenza

Influenza testing

Procedure: swab sampling

Interventions

swab samplingPROCEDURE

Multiplex polymerase chain reaction assay for organisms of upper respiratory tract infections

Influenza

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients seeking care at the emergency department of participating hospitals

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rostock

Rostock, 18057, Germany

RECRUITING

MeSH Terms

Conditions

Influenza, HumanEmergencies

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Martin Bienengraeber, Dr.

CONTACT

+49 381 494 5031dekanat.forschung@med.uni-rostock.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy head of Department

Study Record Dates

First Submitted

January 12, 2020

First Posted

January 28, 2020

Study Start

January 27, 2020

Primary Completion

April 1, 2020

Study Completion

August 1, 2020

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

DE(1)