Status:
COMPLETED
Vanderbilt Pertussis Exposure Study: PEP in Vaccinated Healthcare Workers Following Pertussis Exposure
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Pertussis
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
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 an...
Detailed Description
Pertussis, caused by the bacterium Bordetella pertussis, is an acute respiratory tract infection transmitted to susceptible persons through aerosolized respiratory droplets and direct contact with res...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1102 Patients enrolled
Trial Details
Trial ID
NCT00469274
Start Date
May 1 2007
End Date
December 1 2009
Last Update
January 29 2013
Active Locations (1)
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1
Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University Medical Center,
Nashville, Tennessee, United States, 37232