Alere i FluA*B Biologic Test Relocated in Emergency Servi... | NCT03293979

Studies
Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis

NCT03293979

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Aug 9, 2018Actual

Enrollment

301Actual

Phase

Not provided

Conditions

Interventions

Test A i Flu A&B implemented in emergency service

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2016Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Sep 21, 2017

First Submission Date that Met QC Criteria

Sep 21, 2017

First Posted Date

Sep 26, 2017Actual

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

Aug 8, 2018

Last Update Posted Date

Aug 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it was well studied in the last years.However, the economical impact and the organisation benefit in emergency service is not yet evaluated Our purpose is to study the impact of implementation of fast flu diagnosis by molecular biology available in emergency service in the economic field .

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

301Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test A i Flu A&B implemented in emergency service	Diagnostic Test	Test A i Flu A&B implemented in emergency service

Measure	Description	Time Frame
time to have the result of the biological test		3 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

respiratory symptoms
fever >38°C
general symptoms of flu like pathology

Exclusion Criteria:

cognitive disorders
patient with guardianship
patient already having a flu diagnosis in the last 7 days
without social protection.

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

each patient admitted in emergy service between february 2016 and april 2016

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GANANSIA Olivier, MD	GHPSJ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

IPD Sharing Statement Module

Plan to Share IPD

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

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