<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03293979</url>
  </required_header>
  <id_info>
    <org_study_id>TestAiFluA&amp;B</org_study_id>
    <nct_id>NCT03293979</nct_id>
  </id_info>
  <brief_title>Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis</brief_title>
  <official_title>Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It appears that the heavyness of flu pathology, the diagnosis limits and the validity of it&#xD;
      was well studied in the last years.However, the economical impact and the organisation&#xD;
      benefit in emergency service is not yet evaluated Our purpose is to study the impact of&#xD;
      implementation of fast flu diagnosis by molecular biology available in emergency service in&#xD;
      the economic field .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>time to have the result of the biological test</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <enrollment type="Actual">301</enrollment>
  <condition>Flu</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Test A i Flu A&amp;B implemented in emergency service</intervention_name>
    <description>Test A i Flu A&amp;B implemented in emergency service</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        each patient admitted in emergy service between february 2016 and april 2016&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  respiratory symptoms&#xD;
&#xD;
          -  fever &gt;38°C&#xD;
&#xD;
          -  general symptoms of flu like pathology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cognitive disorders&#xD;
&#xD;
          -  patient with guardianship&#xD;
&#xD;
          -  patient already having a flu diagnosis in the last 7 days&#xD;
&#xD;
          -  without social protection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GANANSIA Olivier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHPSJ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293979
org study id: TestAiFluA&B
nct id: NCT03293979
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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 .
observational model: Cohort
time perspective: Prospective
measure: time to have the result of the biological test
time frame: 3 hours
intervention type: Diagnostic Test
intervention name: Test A i Flu A&B implemented in emergency service
description: Test A i Flu A&B implemented in emergency service
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GANANSIA Olivier, MD
role: Principal Investigator
affiliation: GHPSJ
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
sharing ipd: No