- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02846311
Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV
Prospective Evaluation of the Alere i Influenza A&B Nucleic Acid Amplification Versus Xpert Flu/RSV
Study Overview
Detailed Description
Main objective / secondary:
It appears that so far the weight of the influenza disease, the limits of clinical diagnosis and validity of rapid diagnostic methods to emergencies are well studied and validated. However the potential organizational and economic benefit in emergency care services remains little known and rarely evaluated.
The significant improvement in diagnostic response time he has a real beneficial impact for the patient? For the organization of the emergency? Investigators propose to study the impact of the implementation of rapid diagnostic solution by molecular biology of influenza directly available in an adult emergency department, from a cohort of patients consulting in connection a flu-like illness. Investigators wish in particular to highlight the organizational and economic impact.
Methodology :
DESIGN:
Study single-center, prospective, descriptive, observational, type "before / after".
Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), Methodology :
DESIGN:
Study single-center, prospective, descriptive, observational, type "before / after".
Unable to reasonably perform a prospective randomized study due to the constraints for patients and for the service and means that it would be necessary to deploy in this case (CRA ... PHRC), we are moving more towards a comparison study before / after between February and April.
Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)
Acquisition of data:
Data Observing Notebook (CRF or "Case Report Form") are disclosed in the notes accompanying this document and will be collected aur an Excel spreadsheet Statistical analysis ( For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.
Development of the study:
The patient presents to the Emergency Home Service for a "flu syndrome". During the first phase ( "before"), the assumption will be that usually achieved.
During the second phase ( "after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient.
In both cases, the doctor continues to support according to information it has and according to good practice and service protocols.
A case report form (CRF or Case Report Form) is completed for each patient included in the study. This report forms includes a questionnaire that collects anonymous demographic information (patient age and sex) and clinical data. The CRF also includes the results of the rapid test for influenza. These notebooks anonymous comments are seized by the Home Emergency Service on a type of database "Access" (which will then be completed by the results of the rapid test. If positive, strain characterization will be clarified.
Number of patients recruited (justification) and duration of participation for each patient:
Not applicable as observational study are moving more towards a comparison study before / after between February and April.
Time study Total study duration: 3 months Inclusion period: 3 months (February 2016- April 2016)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Ile-de-France
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Paris, Ile-de-France, France, 75014
- Groupe hospitalier Paris saint Joseph
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Respiratory Symptoms include cough, dyspnea and / or
- General symptoms: headache, myalgia, asthenia, anorexia ... and / or
- Acute fever above 38 ° C
- Patient consent.
Exclusion Criteria:
- Major cognitive disorders
- Patient under guardianship
- Patient refusing to consent to research
- Duplicate (patients who have had laboratory diagnosis of influenza in previous 7 days)
- Patient not receiving social security
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group with support that will be usually performed
During the first phase ("before"), the assumption will be that usually achieved. The doctor continues to support according to information it has and according to good practice and service protocols. |
|
Group with a flu test
During the second phase ("after"), a flu test is routinely performed within the home emergency department by the doctor who supports the patient. The doctor continues to support according to information it has and according to good practice and service protocols. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of change of the Length of stay in the emergency service
Time Frame: Day 1
|
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
|
Day 1
|
Assessment of change of Hospitalization rates
Time Frame: Day 1
|
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessments of change of antibiotic treatment Costs
Time Frame: Day1
|
Will be assessed with patients of the firt group (phase 1) and the second one (With Flu Test)
|
Day1
|
Collaborators and Investigators
Investigators
- Principal Investigator: TRABATTONI Eloïse, MD, Groupe hospitalier Paris saint Joseph
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Test iFluA&B
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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