<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/NCT01676974</url>
  </required_header>
  <id_info>
    <org_study_id>COMBAT</org_study_id>
    <nct_id>NCT01676974</nct_id>
  </id_info>
  <brief_title>Carriage Of Multiresistant Bacteria After Travel</brief_title>
  <acronym>COMBAT</acronym>
  <official_title>Impact of International Travel on the Emergence and Spread of Antimicrobial Resistance in The Netherlands</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Utrecht University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: Prospectively study the influence of foreign travel and associated risk factors&#xD;
      on the acquisition of AMR in the endogenous microbiota of healthy individuals and the&#xD;
      subsequent persistence of AMR carriage and transmission to household members of these&#xD;
      carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of&#xD;
      bacterial infections in the year after travel (compared to non-carriers). Explore the full&#xD;
      width of AMR genes and transferable genetic elements acquired during international travel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Antimicrobial resistance (AMR) among Enterobacteriaceae constitutes an&#xD;
      increasingly important human health hazard worldwide. Also in the Netherlands AMR rates have&#xD;
      been on the rise in recent years. A limited number of previous studies have suggested high&#xD;
      acquisition rates of AMR E. coli during international travel, but information on&#xD;
      travel-associated risk factors, duration of colonization and local transmission of imported&#xD;
      AMR are largely, if not entirely, lacking.&#xD;
&#xD;
      Objectives: Prospectively study the influence of foreign travel and associated risk factors&#xD;
      on the acquisition of AMR in the endogenous microbiota of healthy individuals and the&#xD;
      subsequent persistence of AMR carriage and transmission to household members of these&#xD;
      carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of&#xD;
      bacterial infections in the year after travel (compared to non-carriers). Explore the full&#xD;
      width of AMR genes and transferable genetic elements acquired during international travel.&#xD;
&#xD;
      Study design: multicenter longitudinal cohort study.&#xD;
&#xD;
      Study population: healthy, adult (&gt; 18 years) volunteers travelling abroad for 1 week - 3&#xD;
      months. Non travelling household members of these traveling volunteers.&#xD;
&#xD;
      Methods: Travelers and non-traveling household members will be recruited at outpatient travel&#xD;
      clinics throughout The Netherlands. Faecal samples and questionnaires will be taken before&#xD;
      (t=0) travel, immediately after travel (t=1) and 1 month upon return (t = 2). For volunteers&#xD;
      that acquire AMR Enterobacteriaceae, repeated questionnaires and faecal samples will be taken&#xD;
      after 3, 6 and 12 months.&#xD;
&#xD;
      Faecal samples will be cultured to screen for AMR Enterobacteriaceae. Suspected colonies will&#xD;
      be identified and susceptibilities confirmed by standard methods. Genotypic characterization&#xD;
      of the extended-spectrum betalactamase- (ESBL-) and carbapenemase genes will be performed&#xD;
      using microarray and gene sequencing. Clonal bacterial spread within households will be&#xD;
      confirmed or excluded by molecular typing.&#xD;
&#xD;
      Outcomes: The main outcome measure is the acquisition rate and persistence of AMR in the&#xD;
      endogenous microbiota of healthy travelers upon travel.&#xD;
&#xD;
      Secondary outcomes are the duration of colonization, the rate of secondary transmission&#xD;
      within households, the identification of risk factors, occurrence of self-reported infections&#xD;
      in the year following travel and the abundance and type of resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>acquisition rate</measure>
    <time_frame>1 year</time_frame>
    <description>the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of colonization</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of secondary transmission within households</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>identification of risk factors</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>occurrence of self-reported infections in the year following travel</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abundance and type of resistance</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2215</enrollment>
  <condition>Enterobacteriaceae, Infection</condition>
  <arm_group>
    <arm_group_label>Travelers</arm_group_label>
    <description>Travelers and their family members</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fecal Swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Travelers and their family members not planning to travel&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  travelling for &gt; 1 week (7 days) AND &lt; 3 months (90 days)&#xD;
&#xD;
          -  non traveling household members of these traveling volunteers&#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>
  <overall_official>
    <last_name>Menno D. de Jong, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <zip>1100 DD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum</name>
      <address>
        <city>Maastricht</city>
        <zip>6202 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum</name>
      <address>
        <city>Rotterdam</city>
        <zip>3000 CA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>July 29, 2016</last_update_submitted>
  <last_update_submitted_qc>July 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Menno D. de Jong, MD</investigator_full_name>
    <investigator_title>Prof. dr. M.D. de Jong</investigator_title>
  </responsible_party>
  <keyword>Drug Resistance, Microbial</keyword>
  <keyword>Enterobacteriaceae</keyword>
  <keyword>ESBL</keyword>
  <keyword>Carbapenemase</keyword>
  <keyword>Travel</keyword>
  <!-- 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/NCT01676974
org study id: COMBAT
nct id: NCT01676974
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Objectives: Prospectively study the influence of foreign travel and associated risk factors
      on the acquisition of AMR in the endogenous microbiota of healthy individuals and the
      subsequent persistence of AMR carriage and transmission to household members of these
      carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of
      bacterial infections in the year after travel (compared to non-carriers). Explore the full
      width of AMR genes and transferable genetic elements acquired during international travel.
Rationale: Antimicrobial resistance (AMR) among Enterobacteriaceae constitutes an
      increasingly important human health hazard worldwide. Also in the Netherlands AMR rates have
      been on the rise in recent years. A limited number of previous studies have suggested high
      acquisition rates of AMR E. coli during international travel, but information on
      travel-associated risk factors, duration of colonization and local transmission of imported
      AMR are largely, if not entirely, lacking.

      Objectives: Prospectively study the influence of foreign travel and associated risk factors
      on the acquisition of AMR in the endogenous microbiota of healthy individuals and the
      subsequent persistence of AMR carriage and transmission to household members of these
      carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of
      bacterial infections in the year after travel (compared to non-carriers). Explore the full
      width of AMR genes and transferable genetic elements acquired during international travel.

      Study design: multicenter longitudinal cohort study.

      Study population: healthy, adult (> 18 years) volunteers travelling abroad for 1 week - 3
      months. Non travelling household members of these traveling volunteers.

      Methods: Travelers and non-traveling household members will be recruited at outpatient travel
      clinics throughout The Netherlands. Faecal samples and questionnaires will be taken before
      (t=0) travel, immediately after travel (t=1) and 1 month upon return (t = 2). For volunteers
      that acquire AMR Enterobacteriaceae, repeated questionnaires and faecal samples will be taken
      after 3, 6 and 12 months.

      Faecal samples will be cultured to screen for AMR Enterobacteriaceae. Suspected colonies will
      be identified and susceptibilities confirmed by standard methods. Genotypic characterization
      of the extended-spectrum betalactamase- (ESBL-) and carbapenemase genes will be performed
      using microarray and gene sequencing. Clonal bacterial spread within households will be
      confirmed or excluded by molecular typing.

      Outcomes: The main outcome measure is the acquisition rate and persistence of AMR in the
      endogenous microbiota of healthy travelers upon travel.

      Secondary outcomes are the duration of colonization, the rate of secondary transmission
      within households, the identification of risk factors, occurrence of self-reported infections
      in the year following travel and the abundance and type of resistance.
observational model: Ecologic or Community
time perspective: Prospective
measure: acquisition rate
time frame: 1 year
description: the acquisition rate and persistence of AMR in the endogenous microbiota of healthy travelers upon travel
measure: duration of colonization
time frame: 1 year
measure: rate of secondary transmission within households
time frame: 1 year
measure: identification of risk factors
time frame: 1 year
measure: occurrence of self-reported infections in the year following travel
time frame: 1 year
measure: abundance and type of resistance
time frame: 1 year
arm group label: Travelers
description: Travelers and their family members
Fecal Swab
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Menno D. de Jong, PhD, MD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Menno D. de Jong, MD
investigator title: Prof. dr. M.D. de Jong