<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/NCT03757546</url>
  </required_header>
  <id_info>
    <org_study_id>GIVRE</org_study_id>
    <nct_id>NCT03757546</nct_id>
  </id_info>
  <brief_title>Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections</brief_title>
  <acronym>GIVRE</acronym>
  <official_title>Extra-pulmonary Clinical Manifestations of Influenza Virus and Respiratory Syncitial Virus Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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>
      The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza&#xD;
      virus and Respiratory Syncitial Virus infections in hospitalized adults at a French&#xD;
      university hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Influenza virus and Respiratory Syncitial Virus (RSV) could be responsible for severe&#xD;
      infections. Although flu was primarily considered as limited to the respiratory system,&#xD;
      clinical reports suggest its association with organ involvement outside of the respiratory&#xD;
      tract.&#xD;
&#xD;
      The aim of the study is to describe extra-pulmonary complications due to influenza virus and&#xD;
      RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020&#xD;
      in a French university hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">April 14, 2019</completion_date>
  <primary_completion_date type="Actual">March 14, 2019</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>Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data</measure>
    <time_frame>at 1 month</time_frame>
    <description>Clinical data (clinical examination)&#xD;
Biological Data (blood test)&#xD;
Radiological data</description>
  </primary_outcome>
  <enrollment type="Actual">252</enrollment>
  <condition>Influenza</condition>
  <condition>Respiratory Virus Syncitial</condition>
  <condition>Extra-respiratory</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational</intervention_name>
    <description>The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adults hospitalized with flu or RSV infections&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized adults ≥18 years old&#xD;
&#xD;
          -  Flu or RSV infection confirmed by multiplex qPCR on nasal swab&#xD;
&#xD;
          -  Oral non-opposition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No health insurance&#xD;
&#xD;
          -  Co-infection with viruses other than influenza or RSV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</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>Virus Diseases</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <!-- 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/NCT03757546
org study id: GIVRE
nct id: NCT03757546
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to describe extra-pulmonary clinical manifestations of Influenza
      virus and Respiratory Syncitial Virus infections in hospitalized adults at a French
      university hospital.
Influenza virus and Respiratory Syncitial Virus (RSV) could be responsible for severe
      infections. Although flu was primarily considered as limited to the respiratory system,
      clinical reports suggest its association with organ involvement outside of the respiratory
      tract.

      The aim of the study is to describe extra-pulmonary complications due to influenza virus and
      RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020
      in a French university hospital.
observational model: Cohort
time perspective: Prospective
measure: Evaluation frequency of extra-respiratory manifestations with clinical, biological and radiological data
time frame: at 1 month
description: Clinical data (clinical examination)
Biological Data (blood test)
Radiological data
intervention type: Other
intervention name: observational
description: The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Virus Diseases
mesh term: Influenza, Human