<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/NCT02198638</url>
  </required_header>
  <id_info>
    <org_study_id>2013.814</org_study_id>
    <secondary_id>2012-A01503-40</secondary_id>
    <nct_id>NCT02198638</nct_id>
  </id_info>
  <brief_title>Effect of Influenza Vaccination of Healthcare Workers (HCW) on the Risk of Influenza in Patients Hospitalized in Short Stays Units</brief_title>
  <official_title>Influenza Vaccination of HCW and Hospital Acquired Influenza in Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hospital acquired influenza is associated with significant morbidity and mortality in&#xD;
      hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent&#xD;
      influenza transmission in healthcare setting.&#xD;
&#xD;
      Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in&#xD;
      patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in&#xD;
      the elderly population will not necessarily result in a total control of the incidence.&#xD;
      Consequently, the prevention of influenza outbreaks in this vulnerable population must also&#xD;
      include the reduction of the exposure to the influenza viruses, in particular thanks to the&#xD;
      vaccination of HCW.&#xD;
&#xD;
      A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University&#xD;
      hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital&#xD;
      acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results&#xD;
      suggest a protective effect but investigations, carried out on a more important sample are&#xD;
      needed to validate the benefit of HCW vaccination.&#xD;
&#xD;
      The aim of this prospective multicentric cohort study is to estimate incidence of influenza&#xD;
      among hospitalized patients according to % of influenza vaccination of HCW in short stay&#xD;
      units.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units</measure>
    <time_frame>After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)</time_frame>
    <description>Study participation was proposed to each patient who presented ILI (influenza like illness) at admission or during hospitalization. ILI was defined as fever &gt;37.8°C or cough or sore throat. Vaccination against influenza during the ILI season was collected by oral interview. After the interview, a nasal swab was performed by a research assistant and influenza virus infection was confirmed by enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction on viral cultures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimation of influenza vaccine failure according to serotyping of viral strains</measure>
    <time_frame>After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)</time_frame>
    <description>strains of confirmed influenza virus were analysed by reverse transcription-polymerase chain reaction on viral cultures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Does incidence of community influenza influence hospital acquired influenza infections</measure>
    <time_frame>After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)</time_frame>
    <description>comparison of results observed during the 2 seasons</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">541</enrollment>
  <condition>Patient With Influenza Like Illness</condition>
  <arm_group>
    <arm_group_label>Patients or healthcare workers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>A nasal swab</intervention_name>
    <description>A nasal swab was performed by a research assistant and influenza virus infection was confirmed by enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction on viral cultures</description>
    <arm_group_label>Patients or healthcare workers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adults patients and healthcare workers of the participating units&#xD;
&#xD;
          -  With Influenza Like Illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Hôpital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire - Saint Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>May 12, 2015</last_update_submitted>
  <last_update_submitted_qc>May 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Vaccination rate</keyword>
  <keyword>Hospital acquired infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02198638
org study id: 2013.814
secondary id: 2012-A01503-40
nct id: NCT02198638
lead sponsor: 
has dmc: No
Hospital acquired influenza is associated with significant morbidity and mortality in
      hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent
      influenza transmission in healthcare setting.

      Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in
      patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in
      the elderly population will not necessarily result in a total control of the incidence.
      Consequently, the prevention of influenza outbreaks in this vulnerable population must also
      include the reduction of the exposure to the influenza viruses, in particular thanks to the
      vaccination of HCW.

      A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University
      hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital
      acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results
      suggest a protective effect but investigations, carried out on a more important sample are
      needed to validate the benefit of HCW vaccination.

      The aim of this prospective multicentric cohort study is to estimate incidence of influenza
      among hospitalized patients according to % of influenza vaccination of HCW in short stay
      units.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units
time frame: After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)
description: Study participation was proposed to each patient who presented ILI (influenza like illness) at admission or during hospitalization. ILI was defined as fever >37.8°C or cough or sore throat. Vaccination against influenza during the ILI season was collected by oral interview. After the interview, a nasal swab was performed by a research assistant and influenza virus infection was confirmed by enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction on viral cultures.
measure: Estimation of influenza vaccine failure according to serotyping of viral strains
time frame: After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)
description: strains of confirmed influenza virus were analysed by reverse transcription-polymerase chain reaction on viral cultures.
measure: Does incidence of community influenza influence hospital acquired influenza infections
time frame: After 16 months (2 influenza seasons: from 15 December 2013 to 15 April 2014 and from 15 December 2014 to 15 April 2015)
description: comparison of results observed during the 2 seasons
arm group label: Patients or healthcare workers
arm group type: Other
intervention type: Biological
intervention name: A nasal swab
description: A nasal swab was performed by a research assistant and influenza virus infection was confirmed by enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction on viral cultures
arm group label: Patients or healthcare workers
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Influenza, Human