Carriage of Bordetella PertussisNCT02215564
Bordetella Pertussis Carriage in College-aged Students
An observational study of Carriage of Bordetella Pertussis, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carriage of Bordetella Pertussis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: College-aged students/young adults
Who may be able to join
- Age 18 and above
- Not immunosuppressed
- Not HIV positive (not known to be/self-reported)
- Able to tolerate swab procedures
- Able to provide consent
Who cannot join
- No antimicrobial or immunosuppressive medications taken for chronic conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
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.
- Conditions
- Carriage of Bordetella Pertussis
- Keywords
- Bordetella pertussis, Carriage rates in young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Young adults tested by PCR for B. pertussis carriage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carriage of Bordetella PertussisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Owen Hendley, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215564
- Sponsor's protocol ID
- 17545
- Status last verified
- May 2015
- First submitted
- 6 Aug 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21046700Zhang 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.
PubMed 24520981
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bordetella Pertussis Carriage in College-aged Students
- ClinicalTrials.gov ID
- NCT02215564
- Acronym / sponsor ID
- 17545
- Conditions
- Carriage of Bordetella Pertussis
- Keywords
- Bordetella pertussis, Carriage rates in young adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 13 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Young adults tested by PCR for B. pertussis carriage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- College-aged students/young adults
Key inclusion criteria (5 listed)
- Age 18 and above
- Not immunosuppressed
- Not HIV positive (not known to be/self-reported)
- Able to tolerate swab procedures
- Able to provide consent
Key exclusion criteria (1 listed)
- No antimicrobial or immunosuppressive medications taken for chronic conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Number of participants with B. pertussis by PCR in nasopharyngeal sample at second timepoint
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 21046700Nuolivirta 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.
- Background: PubMed 24520981Zhang 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carriage of Bordetella Pertussis, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with B. pertussis by PCR in nasopharyngeal sample at first timepoint (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02215564, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.