Carriage of Bordetella Pertussis Clinical Trial
Official title:
Bordetella Pertussis Carriage in College-aged Students
| Verified date | May 2015 |
| Source | University of Virginia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 150 |
| Est. completion date | August 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Virginia Health System | Charlottesville | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Virginia |
United States,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of participants with B. pertussis by PCR in nasopharyngeal sample at third timepoint | Participants will be tested for B. pertussis by PCR at one visit in April 2015, 30 minutes. | 30 minutes | No |
| Primary | Number of participants with B. pertussis by PCR in nasopharyngeal sample at first timepoint | Participants will be tested for B. pertussis by PCR at one visit in October 2014, 30 minutes. | 30 minutes | No |
| Secondary | Number of participants with B. pertussis by PCR in nasopharyngeal sample at second timepoint | Participants will be tested for B. pertussis by PCR at one visit in January 2015, 30 minutes. | 30 minutes | No |