Retrospective Observational Study on the Epidemiological... | NCT04110990

Studies
Retrospective Observational Study on the Epidemiological Characteristics of Influenza Patients

NCT04110990

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Oct 2, 2019Actual

Enrollment

384Estimated

Phase

Not provided

Conditions

Influenza

Interventions

Not provided

Countries

France

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2019Estimated

Primary Completion Date

Oct 2019Estimated

Completion Date

Oct 2020Estimated

First Submitted Date

Sep 27, 2019

First Submission Date that Met QC Criteria

Sep 30, 2019

First Posted Date

Oct 1, 2019Actual

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

Sep 30, 2019

Last Update Posted Date

Oct 2, 2019Actual

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

Seasonal influenza outbreaks contribute to the saturation of emergency services. Better knowledge of the epidemiology and clinical presentation of this pathology would optimize the organization of emergency reception services and provide better care for patients, disseminate educational elements to the population more appropriate as well as optimal recommendations for health professionals.

Detailed Description

Not provided

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

384Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospectively study of the epidemiological characteristics of influenza patients consulted at the Adult Emergencies of Strasbourg University Hospitals		Files analyzed retrospectily from September 1st, 2018 to March 30, 2019 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Major subject ((≥18 years old)
Subject who consulted the Emergency Department of the Adult Emergencies of the Strasbourg University Hospitals between September 2018 and March 2019
Subject for which the flu smear is positive
Subject not expressing opposition to the use of his data for research purposes

Exclusion criteria:

Subject having expressed his opposition to participating in the study
Subject for which the flu smear is negative
Subject under the protection of justice
Subject under guardianship or curators

Accepts Healthy Volunteers

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

Patient who consulted the Emergency Department of the Adult Emergencies of the Strasbourg University Hospitals between September 2018 and March 2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christine Kummerlen, MD	Contact	33 3 88 11 67 68		christine.kummerlen@chru-strasbourg.fr
Louise-Marie Jandeaux, MD	Contact	33 3 88 11 67 68		louise-marie.jandeaux@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Christine Kummerlen, MD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de réanimation médicale		Strasbourg		67098	France

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided