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PEPtalk2: results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer.

Bate, J; Baker, S; Breuer, J; Chisholm, JC; Gray, J; Hambleton, S; Houlton, A; Jit, M; Lowis, S; Makin, G; et al. Bate, J; Baker, S; Breuer, J; Chisholm, JC; Gray, J; Hambleton, S; Houlton, A; Jit, M; Lowis, S; Makin, G; O'Sullivan, C; Patel, SR; Phillips, R; Ransinghe, N; Ramsay, ME; Skinner, R; Wheatley, K; Heath, PT (2019) PEPtalk2: results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer. Arch Dis Child, 104 (1). pp. 25-29. ISSN 1468-2044 https://doi.org/10.1136/archdischild-2017-314212
SGUL Authors: Heath, Paul Trafford

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Abstract

OBJECTIVE: To determine the likely rate of patient randomisation and to facilitate sample size calculation for a full-scale phase III trial of varicella zoster immunoglobulin (VZIG) and aciclovir as postexposure prophylaxis against chickenpox in children with cancer. DESIGN: Multicentre pilot randomised controlled trial of VZIG and oral aciclovir. SETTING: England, UK. PATIENTS: Children under 16 years of age with a diagnosis of cancer: currently or within 6 months of receiving cancer treatment and with negative varicella zoster virus (VZV) serostatus at diagnosis or within the last 3 months. INTERVENTIONS: Study participants who have a significant VZV exposure were randomised to receive PEP in the form of VZIG or aciclovir after the exposure. MAIN OUTCOME MEASURES: Number of patients registered and randomised within 12 months of the trial opening to recruitment and incidence of breakthrough varicella. RESULTS: The study opened in six sites over a 13-month period. 482 patients were screened for eligibility, 32 patients were registered and 3 patients were randomised following VZV exposure. All three were randomised to receive aciclovir and there were no cases of breakthrough varicella. CONCLUSIONS: Given the limited recruitment to the PEPtalk2 pilot, it is unlikely that the necessary sample size would be achievable using this strategy in a full-scale trial. The study identified factors that could be used to modify the design of a definitive trial but other options for defining the best means to protect such children against VZV should be explored. TRIAL REGISTRATION NUMBER: ISRCTN48257441, EudraCT number: 2013-001332-22, sponsor: University of Birmingham.

Item Type: Article
Additional Information: This article has been accepted for publication in Archives of Disease in Childhood following peer review. The definitive copyedited, typeset version Bate J, Baker S, Breuer J, et al PEPtalk2: results of a pilot randomised controlled trial to compare VZIG and aciclovir as postexposure prophylaxis (PEP) against chickenpox in children with cancer Archives of Disease in Childhood 2019;104:25-29 is available online at: http://dx.doi.org/10.1136/archdischild-2017-314212
Keywords: paediatric haematology, paediatric oncology, prophylaxis, varicella, paediatric haematology, paediatric oncology, prophylaxis, varicella, Pediatrics, 1103 Clinical Sciences, 1114 Paediatrics And Reproductive Medicine, 1117 Public Health And Health Services
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Arch Dis Child
ISSN: 1468-2044
Language: eng
Dates:
DateEvent
January 2019Published
5 May 2018Published Online
17 April 2018Accepted
Publisher License: Publisher's own licence
Projects:
Project IDFunderFunder ID
PB-PG-0211-24142National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
HPRU-2012-10096National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 29730641
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/109856
Publisher's version: https://doi.org/10.1136/archdischild-2017-314212

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