Vanderbilt Pertussis Exposure Study: PEP in Vaccinated Healthcare Workers Following Pertussis Exposure

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Centers for Disease Control and Prevention
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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