Burden of Influenza at Emergency Department (ED) Level in... | NCT04244500

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

NCT04244500

Sponsor

University of Rostock

Status

Unknown status

Last Update Posted

Jan 28, 2020Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Influenza, Human

Interventions

swab sampling

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2020Actual

Primary Completion Date

Apr 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Jan 12, 2020

First Submission Date that Met QC Criteria

Jan 26, 2020

First Posted Date

Jan 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2020

Last Update Posted Date

Jan 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. med. Micha Loebermann, Deputy head of Department, University of RostockPrincipal Investigator

Lead Sponsor

University of RostockOTHER

Collaborators

Name	Class
Klinikum Ernst von Bergmann Potsdam	UNKNOWN
Klinikum Suedstadt, Rostock	UNKNOWN
Sanofi Pasteur, a Sanofi Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Influenza		Influenza testing	Procedure: swab sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
swab sampling	Procedure	Multiplex polymerase chain reaction assay for organisms of upper respiratory tract infections	Influenza

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
demographic and medical profile	demographic and medical profile of influenza-related and non-influenza-related visits	at admission to ED
socio-demographic or other risk factors	Identify socio-demographic or other risk factors associated with ED visit outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients seeking care at the emergency department of participating hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martin Bienengraeber, Dr.	Contact	+49 381 494 5031		dekanat.forschung@med.uni-rostock.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rostock	Recruiting	Rostock		18057	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human
D004630	Emergencies

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

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Browse Branches

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