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PertussisVPESNCT00469274

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

A study testing Antibiotic PEP in people with Pertussis, run by Vanderbilt University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Pertussis
What is being tested?
Antibiotic PEP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,102 participants
Where
1 siteUnited States
Study dates
May 2007to Dec 2009
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Monroe Carell Jr. Children's Hospital at Vanderbilt, Vanderbilt University Medical Center,

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: A Randomized Open-Label Non-Inferiority Study to Examine the Impact of Pertussis Vaccination of Healthcare Workers on Post-exposure Prophylaxis

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.

Read the 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 respiratory secretions. Classic pertussis disease is characterized by three phases of illness: the catarrhal phase where persons note cough and coryza; the paroxysmal phase where persons develop a spasmodic cough with post-tussive vomiting and an inspiratory whoop; and the convalescent phase, during which symptoms slowly resolve. The risk of transmission of the organism is compounded by the nondescript nature of symptoms early in the course of illness, particularly in adults. Classically recognized as a disease of infants and children ("whooping cough"), the incidence of pertussis infection in adolescents and adults has increased in recent years. Persons >15 years of age now make up more than twenty percent of reported cases. This increase is likely due to several factors, including waning protection from childhood vaccination and natural infection, an increased appreciation for disease in adolescents and adults, and the improved ability of clinicians to diagnose pertussis recognition through the use of serologic methods.

Healthcare workers (HCWs) are at increased risk for acquiring pertussis infection due to regular contact with infected patients and waning protection from childhood vaccination or from natural pertussis infection. Healthcare-associated outbreaks of pertussis have also been increasingly recognized and have been reported from a diverse range of healthcare facilities. Such outbreaks are often due to under-recognition of pertussis with subsequent failure to isolate suspected cases, waning immunity from childhood vaccination or disease, and the increasing incidence of pertussis infection in adults and adolescents. Infected HCWs can then serve as vectors of infection to other susceptible contacts including patients, other employees, and even their own children.

Vaccination is an effective tool for the prevention of pertussis. In 2005, two tetanus toxoid, reduced diphtheria toxoid, and reduced antigen quantity acellular pertussis vaccines (Tdap) were licensed for use in adolescents and adults. In view of the increasingly recognized problem of healthcare-associated and transmitted pertussis infection, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) targeted HCWs as a priority group for pertussis vaccination in 2006, primarily to reduce the risk of spread of pertussis within health care institutions.

Until the licensure of Tdap, the only method to reduce transmission of pertussis after healthcare-associated exposure to persons with pertussis was post-exposure prophylaxis (PEP) with antibiotics and employee furlough. Close contacts exposed to a pertussis-infected patient or staff member are routinely treated with macrolide therapy (erythromycin or azithromycin), and exposed HCWs who develop a cough-illness are restricted from work for 5 days while on antibiotic therapy. PEP is believed to prevent symptomatic infection in the exposed person if administered within 21 days of cough onset. Traditionally, decisions regarding PEP for exposed HCWs involve detailed assessments of the degree of patient contact, the risk for development of severe or complicated pertussis, and regular evaluation and follow-up for the occurrence of symptoms. These are often time-consuming efforts that are usually the responsibility of infection control or occupational health personnel. With the licensure of Tdap and with the recommended vaccination of HCWs, it is now hoped that vaccination will eliminate the need to provide antibiotic PEP, particularly in recently-vaccinated HCWs. However, this has not been confirmed with a randomized clinical trial, and, therefore, no definitive formal recommendation can be made regarding modifications of PEP in vaccinated HCWs. Two potential strategies exist for the management of vaccinated HCWs following an exposure to a person with pertussis: a) provision of universal antibiotic therapy or b) careful daily observation of vaccinated HCWs for the development of symptoms without antibiotic prescription. A comparison of these two strategies will be the focus of this study.

Conditions
Pertussis
Being tested
Antibiotic PEP
Keywords
Pertussis, Healthcare worker, Post-exposure prophylaxis, Vaccination, Pertussis in healthcare workers following occupational, exposure to pertussis
Medical subject headings
Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Antibiotic PEPDrug

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

  • Antibiotic PEPDrug

    TMP-SMX DS po BID for 14 days

Study groups in NCT00469274
Study groupRoleWhat they receive
Antibiotic PEPActive comparatorSubjects who did receive PEP following pertussis exposure
Receives: Drug: Antibiotic PEP
No PEPNo interventionSubjects who did not receive PEP following pertussis exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: In the 21 days following exposure identification

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00469274
Sponsor's protocol ID
VPES
Acronym
VPES
Status last verified
Dec 2012
First submitted
3 May 2007
Last updated
29 Jan 2013
Data monitoring committee
No

Publications

  • 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.

    PubMed 22238169

Questions about this trial

What is this clinical trial studying?

A study testing Antibiotic PEP in people with Pertussis, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence of Pertussis Infection in Each PEP Arm, Defined Using Clinical, Microbiologic, or Serologic Criteria. (time frame: In the 21 days following exposure identification). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00469274, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.

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