N/A
N=86
Vanderbilt Pertussis Exposure Study: PEP in Vaccinated Healthcare Workers Following Pertussis Exposure
Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT00469274 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria. — 6; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Antibiotic PEP (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria. |
6; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00469274). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.