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Bordetella Pertussis Carriage in College-aged Students

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ClinicalTrials.gov Identifier: NCT02215564
Recruitment Status : Unknown
Verified May 2015 by J. Owen Hendley, MD, University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : August 13, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
J. Owen Hendley, MD, University of Virginia

Brief Summary:
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.

Condition or disease
Carriage of Bordetella Pertussis

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bordetella Pertussis Carriage in College-aged Students
Study Start Date : October 2014
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough

Group/Cohort
No treatment
Young adults tested by PCR for B. pertussis carriage



Primary Outcome Measures :
  1. Number of participants with B. pertussis by PCR in nasopharyngeal sample at first timepoint [ Time Frame: 30 minutes ]
    Participants will be tested for B. pertussis by PCR at one visit in October 2014, 30 minutes.


Secondary Outcome Measures :
  1. Number of participants with B. pertussis by PCR in nasopharyngeal sample at second timepoint [ Time Frame: 30 minutes ]
    Participants will be tested for B. pertussis by PCR at one visit in January 2015, 30 minutes.


Other Outcome Measures:
  1. Number of participants with B. pertussis by PCR in nasopharyngeal sample at third timepoint [ Time Frame: 30 minutes ]
    Participants will be tested for B. pertussis by PCR at one visit in April 2015, 30 minutes.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
College-aged students/young adults
Criteria

Inclusion Criteria:

  • Age 18 and above
  • Not immunosuppressed
  • Not HIV positive (not known to be/self-reported)
  • Able to tolerate swab procedures
  • Able to provide consent

Exclusion Criteria:

  • No antimicrobial or immunosuppressive medications taken for chronic conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215564


Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia

Publications:
Responsible Party: J. Owen Hendley, MD, Professor of Pediatrics, University of Virginia
ClinicalTrials.gov Identifier: NCT02215564     History of Changes
Other Study ID Numbers: 17545
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by J. Owen Hendley, MD, University of Virginia:
Bordetella pertussis
Carriage rates in young adults

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases