<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/NCT02215564</url>
  </required_header>
  <id_info>
    <org_study_id>17545</org_study_id>
    <nct_id>NCT02215564</nct_id>
  </id_info>
  <brief_title>Bordetella Pertussis Carriage in College-aged Students</brief_title>
  <official_title>Bordetella Pertussis Carriage in College-aged Students</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective in this observational cohort study of young adults sampled at three intervals&#xD;
      during the academic year is to ascertain if there is carriage of B. pertussis in asymptomatic&#xD;
      individuals. We hypothesize that in asymptomatic college students there is no carriage of B.&#xD;
      pertussis detectable by polymerase chain reaction (PCR) assay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</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>Number of participants with B. pertussis by PCR in nasopharyngeal sample at first timepoint</measure>
    <time_frame>30 minutes</time_frame>
    <description>Participants will be tested for B. pertussis by PCR at one visit in October 2014, 30 minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with B. pertussis by PCR in nasopharyngeal sample at second timepoint</measure>
    <time_frame>30 minutes</time_frame>
    <description>Participants will be tested for B. pertussis by PCR at one visit in January 2015, 30 minutes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with B. pertussis by PCR in nasopharyngeal sample at third timepoint</measure>
    <time_frame>30 minutes</time_frame>
    <description>Participants will be tested for B. pertussis by PCR at one visit in April 2015, 30 minutes.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Carriage of Bordetella Pertussis</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>Young adults tested by PCR for B. pertussis carriage</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        College-aged students/young adults&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and above&#xD;
&#xD;
          -  Not immunosuppressed&#xD;
&#xD;
          -  Not HIV positive (not known to be/self-reported)&#xD;
&#xD;
          -  Able to tolerate swab procedures&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No antimicrobial or immunosuppressive medications taken for chronic conditions&#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>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Nuolivirta K, Koponen P, He Q, Halkosalo A, Korppi M, Vesikari T, Helminen M. Bordetella pertussis infection is common in nonvaccinated infants admitted for bronchiolitis. Pediatr Infect Dis J. 2010 Nov;29(11):1013-5.</citation>
    <PMID>21046700</PMID>
  </reference>
  <reference>
    <citation>Zhang Q, Yin Z, Li Y, Luo H, Shao Z, Gao Y, Xu L, Kan B, Lu S, Zhang Y, Li M, Liu M, Yao P, Zhao Z, He Q. Prevalence of asymptomatic Bordetella pertussis and Bordetella parapertussis infections among school children in China as determined by pooled real-time PCR: a cross-sectional study. Scand J Infect Dis. 2014 Apr;46(4):280-7. doi: 10.3109/00365548.2013.878034. Epub 2014 Feb 13.</citation>
    <PMID>24520981</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>J. Owen Hendley, MD</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Bordetella pertussis</keyword>
  <keyword>Carriage rates in young adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Whooping Cough</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/NCT02215564
org study id: 17545
nct id: NCT02215564
lead sponsor: 
has dmc: No
The objective in this observational cohort study of young adults sampled at three intervals
      during the academic year is to ascertain if there is carriage of B. pertussis in asymptomatic
      individuals. We hypothesize that in asymptomatic college students there is no carriage of B.
      pertussis detectable by polymerase chain reaction (PCR) assay.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with B. pertussis by PCR in nasopharyngeal sample at first timepoint
time frame: 30 minutes
description: Participants will be tested for B. pertussis by PCR at one visit in October 2014, 30 minutes.
measure: Number of participants with B. pertussis by PCR in nasopharyngeal sample at second timepoint
time frame: 30 minutes
description: Participants will be tested for B. pertussis by PCR at one visit in January 2015, 30 minutes.
measure: Number of participants with B. pertussis by PCR in nasopharyngeal sample at third timepoint
time frame: 30 minutes
description: Participants will be tested for B. pertussis by PCR at one visit in April 2015, 30 minutes.
arm group label: No treatment
description: Young adults tested by PCR for B. pertussis carriage
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Nuolivirta K, Koponen P, He Q, Halkosalo A, Korppi M, Vesikari T, Helminen M. Bordetella pertussis infection is common in nonvaccinated infants admitted for bronchiolitis. Pediatr Infect Dis J. 2010 Nov;29(11):1013-5.
PMID: 21046700
citation: Zhang Q, Yin Z, Li Y, Luo H, Shao Z, Gao Y, Xu L, Kan B, Lu S, Zhang Y, Li M, Liu M, Yao P, Zhao Z, He Q. Prevalence of asymptomatic Bordetella pertussis and Bordetella parapertussis infections among school children in China as determined by pooled real-time PCR: a cross-sectional study. Scand J Infect Dis. 2014 Apr;46(4):280-7. doi: 10.3109/00365548.2013.878034. Epub 2014 Feb 13.
PMID: 24520981
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: J. Owen Hendley, MD
investigator title: Professor of Pediatrics
mesh term: Whooping Cough