Vanderbilt Pertussis Exposure Study: PEP in Vaccinated Healthcare Workers Following Pertussis Exposure
Completed · Not applicable
Conditions studied: Pertussis
In brief
The purpose of this study is to compare the effectiveness of two strategies of post-exposure prophylaxis (PEP) in healthcare workers (HCWs) who have been vaccinated with acellular pertussis vaccine and have been exposed to pertussis Secondary Objectives include a comparison of the costs of each PEP strategy and an assessment for risk factors associated with healthcare-associated acquisition of pertussis.
Key facts
- Study ID
- NCT00469274
- Run by
- Vanderbilt University
- People needed
- 1102
- Starts
- 2007-05-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2013-01-29
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults age 18 - 64 years
- HCW (defined as any healthcare provider with direct patient care duties) who works at VCH (may be primary or secondary place of employment)
- Willing to sign informed consent and authorization for release of information to the Occupational Health Clinic (OHC) at Vanderbilt University
- Planning to work at VCH for at least one year after enrollment or until anticipated study termination, whichever comes first
- Willing to cooperate with disease and microbiologic surveillance
You may not qualify if…
- Prior receipt of an acellular pertussis vaccine within 5 years prior to enrollment, unless received since Tdap licensure on June 13, 2005
- History of tetanus booster in the 2 years prior to enrollment (excluding Tdap)
- History of allergic or adverse reaction to diphtheria, tetanus, or pertussis vaccines
- Current pregnancy or attempting to become pregnant in the month after enrollment
- Any contraindication to receipt of pertussis vaccine as listed in the ADACEL package insert
- Febrile illness with temperature greater than 38 degrees C in the previous 72 hours (defer enrollment)
- Persons receiving erythromycin, azithromycin, or related antibiotic for prolonged use
- Persons allergic to both macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin) and sulfa antibiotics
- Any condition which, in the opinion of the investigators, may interfere with the evaluation of the study objectives
Where it is running
- Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University Medical Center, — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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