Bordetella Pertussis Carriage in College-aged Students

May 27, 2015 updated by: J. Owen Hendley, MD, University of Virginia
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

College-aged students/young adults

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

June 1, 2015

Study Completion (ANTICIPATED)

August 1, 2015

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (ESTIMATE)

August 13, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17545 (Canadian Orthopedic Foundation Department of Surgery Internal Research Fund)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carriage of Bordetella Pertussis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe