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

NCT00469274 | Completed Results

• 1 other identifier: VPES
• Study Type: interventional
• Target: 1,102
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pertussis

Keywords

Pertussis; Healthcare worker; Post-exposure prophylaxis; Vaccination; Pertussis in healthcare workers following occupational; exposure to pertussis

Outcome Measures

Primary Outcomes (1)

• Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria.

  Defined as a positive nasopharyngeal culture or PCR for B. pertussis at any time point, a two-fold rise in the anti-PT IgG titer between acute and convalescent sera, or a single acute or convalescent anti-PT IgG titer of ≥94 EU. Post hoc, a modified definition was devised because of concern that the serologic criteria used in the primary definition might actually represent acquisition of pertussis infection prior to the intervention. The modified definition of pertussis excluded an acute anti-PT IgG titer of ≥94 EU and an acute nasopharyngeal swab that was positive for B. pertussis by PCR.

  In the 21 days following exposure identification

Study Arms (2)

Antibiotic PEP

ACTIVE COMPARATOR

Subjects who did receive PEP following pertussis exposure

Drug: Antibiotic PEP

No PEP

NO INTERVENTION

Subjects who did not receive PEP following pertussis exposure

Interventions

Antibiotic PEP DRUG

Azithromycin 1000mg po x 1, then 500mg po Q day for 4 days; TMP-SMX DS one BID for 14 days

Antibiotic PEP

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Vanderbilt University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University Medical Center,

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Goins WP, Edwards KM, Vnencak-Jones CL, Rock MT, Swift M, Thayer V, Schaffner W, Talbot TR. A comparison of 2 strategies to prevent infection following pertussis exposure in vaccinated healthcare personnel. Clin Infect Dis. 2012 Apr;54(7):938-45. doi: 10.1093/cid/cir973. Epub 2012 Jan 11.

  PMID: 22238169 DERIVED

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Thomas R. Talbot
• Organization: Vanderbilt University Medical Center

tom.talbot@vanderbilt.edu

615-322-2789

Study Officials

• Thomas R. Talbot, MD MPH

  Vanderbilt University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 29, 2013
• Results First Posted: January 29, 2013

Record last verified: 2012-12

Locations

US (1)