Evidence map›Paper›PMID 22238169›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012

A comparison of 2 strategies to prevent infection following pertussis exposure in vaccinated healthcare personnel.

William P Goins, Kathryn M Edwards, Cindy L Vnencak-Jones, Michael T Rock, Melanie Swift, Valerie Thayer, William Schaffner, Thomas R Talbot

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00469274 (A Randomized Open-Label Non-Inferiority Study to Examine the Impact of Pertussis Vaccination of Healthcare Workers on Post-exposure Prophylaxis), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00469274 nacompletednot on this map

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

TypeinterventionalSponsorVanderbilt UniversityRan2007 to 2009Enrolled1,102ConditionsPertussisArmsAntibiotic PEP
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2018
    Guideline
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

William P GoinsDepartment of Medicine, Division of Infectious Diseases, Baylor College of Medicine, Houston, Texas 77030, USA. goins@bcm.edu
Kathryn M Edwards
Cindy L Vnencak-Jones
Michael T Rock
Melanie Swift
Valerie Thayer
William Schaffner
Thomas R Talbot
Vanderbilt University · USBaylor College of Medicine · USInstitut de Recherche Vaccinale · FR

Funding

VANDERBILT UNIVERSITY CTSA FOR PEDIATRIC RESEARCHUL1RR024975 · NCRR · VANDERBILT UNIVERSITY · PI BERNARD, GORDON RAPHAEL · 2007 to 2011
$45.7M
The Vanderbilt Institute for Clinical and Translational Research (VICTR) KL2KL2RR024977 · NCRR · VANDERBILT UNIVERSITY · PI BERNARD, GORDON RAPHAEL · 2007 to 2011
$3.0M
The Vanderbilt Institute for Clinical and Translational Research (VICTR) TL1TL1RR024978 · NCRR · VANDERBILT UNIVERSITY · PI BERNARD, GORDON RAPHAEL · 2007 to 2011
$1.3M
The Impact of Pertussis Vaccination of Healthcare WorkersU01IP000095 · IP · VANDERBILT UNIVERSITY · PI TALBOT, THOMAS R · 2006 to 2009
$437k
NCIRD CDC HHS 1 U01 IP000095-01NCIRD CDC HHS U01 IP000095NCRR NIH HHS 1 UL1 RR024975NCRR NIH HHS KL2 RR024977NCRR NIH HHS TL1 RR024978NCRR NIH HHS UL1 RR024975
6 · The paper itself

Abstract

backgroundAntibiotic postexposure prophylaxis (PEP) following pertussis exposure is recommended but has never been evaluated in healthcare personnel (HCP) vaccinated with acellular pertussis vaccine (Tdap).

methodsTdap-vaccinated HCP were randomized to receive azithromycin PEP or no PEP following pertussis exposure. Acute and convalescent nasopharyngeal swabs and sera were obtained for pertussis testing by polymerase chain reaction (PCR) and anti-pertussis toxin (PT) immunoglobulin G, respectively. A nasopharyngeal aspirate was also collected for PCR and culture from subjects who reported respiratory symptoms within 21 days following identification of the exposure. Pertussis infection was defined as a positive culture or PCR, a 2-fold rise in anti-PT titer, or a single anti-PT titer of ≥94 enzyme-linked immunosorbent assay units/mL. Daily symptom monitoring without PEP was considered noninferior to PEP after pertussis exposure if the lower limit of the 1-sided 95% confidence interval (CI) for the reduction in pertussis was greater than -7%.

resultsDuring 30 months of study, 86 subjects were randomized following a pertussis exposure. Using the predefined definition of infection, pertussis infection did not develop in 41 (97.6%) of 42 subjects who received azithromycin PEP and 38 (86.4%) of 44 subjects who did not receive PEP (absolute risk difference, -11.3%; lower bound of the 1-sided 95% CI, -20.6%; P = .81). However, no subject developed symptomatic pertussis confirmed with culture or a specific PCR assay, and possibly no subject developed subclinical pertussis infection based upon additional serologic testing.

conclusionsUsing the predefined definition of pertussis infection, noninferiority for preventing pertussis following exposure was not demonstrated for daily symptom monitoring of Tdap-vaccinated HCP without PEP when compared with antibiotic PEP. However, the small number of exposed HCP warrants further study of this approach. CLINICAL

trial registrationNCT00469274.

Indexed as

Health PersonnelOccupational ExposureAdolescentAdultAnti-Bacterial AgentsAntibiotic ProphylaxisAntibodies, BacterialAntitoxinsAzithromycinDiphtheria-Tetanus-acellular Pertussis VaccinesFemaleHumansImmunoglobulin GMaleMiddle AgedNasopharynxAnti-Bacterial AgentsAntibodies, BacterialAntitoxinsAzithromycinDiphtheria-Tetanus-acellular Pertussis VaccinesImmunoglobulin G

Identifiers

PMID22238169
PMCPMC3297652
OpenAlexW2110208824

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.