<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/NCT03306407</url>
  </required_header>
  <id_info>
    <org_study_id>LEK EKNZ 2015-271</org_study_id>
    <nct_id>NCT03306407</nct_id>
  </id_info>
  <brief_title>The Effect of Hand Hygiene on Colonization Rates With Multidrug Resistant Enteric Pathogens in Travellers</brief_title>
  <official_title>A Multicentre Intervention Study on the Use of Hand Sanitizers in the Prevention of Intestinal Colonization With Extended-spectrum Beta-lactamase-producing Enterobacteriaceae in Travellers to the Indian Subcontinent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christoph Hatz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Swiss Tropical &amp; Public Health Institute</source>
  <brief_summary>
    <textblock>
      Travelling to tropical and subtropical countries is a known risk factor for becoming&#xD;
      colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae.&#xD;
      Especially travellers returning from the Indian subcontinent show high colonization rates of&#xD;
      up to almost 90%.&#xD;
&#xD;
      While risk factors for becoming colonized have been identified in several studies, no&#xD;
      preventive measure has been tested so far.&#xD;
&#xD;
      One of the factors associated with becoming colonized while travelling is suffering from&#xD;
      travellers' diarrhoea. Earlier studies looking at diarrhoea in childhood as well as school&#xD;
      and/or work absenteeism because of diarrhoeal diseases have shown protective effects through&#xD;
      good hand hygiene. Furthermore, a recent retrospective study has shown lower rates of&#xD;
      travellers' diarrhoea in people using hand gel sanitizers. Improving hand hygiene in&#xD;
      travellers through increased hand washing and the use of hand gel sanitizers might therefore&#xD;
      not only decrease the rate of travellers' diarrhoea but the carriage rate with ESBL-producing&#xD;
      Enterobacteriaceae as well. However, there is no prospective data available to prove the&#xD;
      usefulness of such an intervention, neither in the prevention of travellers' diarrhoea nor in&#xD;
      the prevention of colonization.&#xD;
&#xD;
      In the current study, investigators plan to compare colonization rates with ESBL-producing&#xD;
      Enterobacteriaceae in travellers receiving pre-travel advice on improved hand hygiene&#xD;
      (including the use of hand gel sanitizers) with travelers receiving standard advice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia</measure>
    <time_frame>up to 1 week after travel</time_frame>
    <description>Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)</measure>
    <time_frame>up to 2 weeks after travel</time_frame>
    <description>Incidence of travellers' diarrhoe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">290</enrollment>
  <condition>Drug Resistance, Multiple</condition>
  <condition>Travel Medicine</condition>
  <arm_group>
    <arm_group_label>Baseline Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received pre-travel advice with special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Improved hand hygiene</intervention_name>
    <description>The intervention group receives pre-travel advice with a special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention)</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  travelling to the Indian subcontinent (India, Bhutan and/or Nepal) for up to 4 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  travelling to other destinations than India, Bhutan and/or Nepal&#xD;
&#xD;
          -  antibiotic treatment at the time of the first sampling&#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>Swiss Tropical and Public Health Institute</name>
      <address>
        <city>Basel</city>
        <zip>4051</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epidemiology, Biostatistics and Prevention Institute</name>
      <address>
        <city>Zurich</city>
        <zip>8001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Kuenzli E, Jaeger VK, Frei R, Neumayr A, DeCrom S, Haller S, Blum J, Widmer AF, Furrer H, Battegay M, Endimiani A, Hatz C. High colonization rates of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli in Swiss travellers to South Asia- a prospective observational multicentre cohort study looking at epidemiology, microbiology and risk factors. BMC Infect Dis. 2014 Oct 1;14:528. doi: 10.1186/1471-2334-14-528.</citation>
    <PMID>25270732</PMID>
  </reference>
  <reference>
    <citation>Kantele A, Laaveri T, Mero S, Vilkman K, Pakkanen SH, Ollgren J, Antikainen J, Kirveskari J. Antimicrobials increase travelers' risk of colonization by extended-spectrum betalactamase-producing Enterobacteriaceae. Clin Infect Dis. 2015 Mar 15;60(6):837-46. doi: 10.1093/cid/ciu957. Epub 2015 Jan 21.</citation>
    <PMID>25613287</PMID>
  </reference>
  <reference>
    <citation>Paltansing S, Vlot JA, Kraakman ME, Mesman R, Bruijning ML, Bernards AT, Visser LG, Veldkamp KE. Extended-spectrum beta-lactamase-producing enterobacteriaceae among travelers from the Netherlands. Emerg Infect Dis. 2013 Aug;19(8):1206-13. doi: 10.3201/eid.1908.130257.</citation>
    <PMID>23885972</PMID>
  </reference>
  <reference>
    <citation>Henriey D, Delmont J, Gautret P. Does the use of alcohol-based hand gel sanitizer reduce travellers' diarrhea and gastrointestinal upset?: A preliminary survey. Travel Med Infect Dis. 2014 Sep-Oct;12(5):494-8. doi: 10.1016/j.tmaid.2014.07.002. Epub 2014 Jul 11.</citation>
    <PMID>25065273</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 9, 2015</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 1, 2018</last_update_submitted>
  <last_update_submitted_qc>October 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Swiss Tropical &amp; Public Health Institute</investigator_affiliation>
    <investigator_full_name>Christoph Hatz</investigator_full_name>
    <investigator_title>Prof. Dr. med. Christoph Hatz</investigator_title>
  </responsible_party>
  <!-- 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/NCT03306407
org study id: LEK EKNZ 2015-271
nct id: NCT03306407
lead sponsor: 
collaborator: 
Travelling to tropical and subtropical countries is a known risk factor for becoming
      colonized with extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae.
      Especially travellers returning from the Indian subcontinent show high colonization rates of
      up to almost 90%.

      While risk factors for becoming colonized have been identified in several studies, no
      preventive measure has been tested so far.

      One of the factors associated with becoming colonized while travelling is suffering from
      travellers' diarrhoea. Earlier studies looking at diarrhoea in childhood as well as school
      and/or work absenteeism because of diarrhoeal diseases have shown protective effects through
      good hand hygiene. Furthermore, a recent retrospective study has shown lower rates of
      travellers' diarrhoea in people using hand gel sanitizers. Improving hand hygiene in
      travellers through increased hand washing and the use of hand gel sanitizers might therefore
      not only decrease the rate of travellers' diarrhoea but the carriage rate with ESBL-producing
      Enterobacteriaceae as well. However, there is no prospective data available to prove the
      usefulness of such an intervention, neither in the prevention of travellers' diarrhoea nor in
      the prevention of colonization.

      In the current study, investigators plan to compare colonization rates with ESBL-producing
      Enterobacteriaceae in travellers receiving pre-travel advice on improved hand hygiene
      (including the use of hand gel sanitizers) with travelers receiving standard advice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Colonization rates with ESBL-producing Enterobacteriaceae in travellers returning from South Asia
time frame: up to 1 week after travel
description: Coloinzation rates with ESBL-producing Enterobacteriaceae in travellers
measure: Incidence of travellers' diarrhoea (during and up to 2 weeks after travelling, assessed through self-reporting)
time frame: up to 2 weeks after travel
description: Incidence of travellers' diarrhoe
arm group label: Baseline Group
arm group type: No Intervention
description: Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received standard pre-travel advice
arm group label: Intervention Group
arm group type: Active Comparator
description: Group screened for colonization with ESBL-producing Enterobacteriaceae pre- and post-travel after having received pre-travel advice with special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention)
intervention type: Other
intervention name: Improved hand hygiene
description: The intervention group receives pre-travel advice with a special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention)
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Switzerland
citation: Kuenzli E, Jaeger VK, Frei R, Neumayr A, DeCrom S, Haller S, Blum J, Widmer AF, Furrer H, Battegay M, Endimiani A, Hatz C. High colonization rates of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli in Swiss travellers to South Asia- a prospective observational multicentre cohort study looking at epidemiology, microbiology and risk factors. BMC Infect Dis. 2014 Oct 1;14:528. doi: 10.1186/1471-2334-14-528.
PMID: 25270732
citation: Kantele A, Laaveri T, Mero S, Vilkman K, Pakkanen SH, Ollgren J, Antikainen J, Kirveskari J. Antimicrobials increase travelers' risk of colonization by extended-spectrum betalactamase-producing Enterobacteriaceae. Clin Infect Dis. 2015 Mar 15;60(6):837-46. doi: 10.1093/cid/ciu957. Epub 2015 Jan 21.
PMID: 25613287
citation: Paltansing S, Vlot JA, Kraakman ME, Mesman R, Bruijning ML, Bernards AT, Visser LG, Veldkamp KE. Extended-spectrum beta-lactamase-producing enterobacteriaceae among travelers from the Netherlands. Emerg Infect Dis. 2013 Aug;19(8):1206-13. doi: 10.3201/eid.1908.130257.
PMID: 23885972
citation: Henriey D, Delmont J, Gautret P. Does the use of alcohol-based hand gel sanitizer reduce travellers' diarrhea and gastrointestinal upset?: A preliminary survey. Travel Med Infect Dis. 2014 Sep-Oct;12(5):494-8. doi: 10.1016/j.tmaid.2014.07.002. Epub 2014 Jul 11.
PMID: 25065273
responsible party type: Sponsor-Investigator
investigator affiliation: Swiss Tropical & Public Health Institute
investigator full name: Christoph Hatz
investigator title: Prof. Dr. med. Christoph Hatz