Short course daily prednisolone therapy during an upper respiratory tract infection in children with relapsing steroid-sensitive nephrotic syndrome (PREDNOS 2): protocol for a randomised controlled trial

Trials

Natalie J Ives³  Wendy Cook⁷  Karl McKeever⁷  Caroline Jones⁷  Jenny Booth⁷  Rodney D Gilbert⁷  Eric R Finlay⁷  Shivram Hegde⁷  Heather Maxwell⁷  Ania Koziell²  Angela S Hall⁴  Martin Christian⁵  Moin A Saleem⁸  Detlef Bockenhauer¹  David V Milford⁹  Elizabeth A Brettell³  Emma Frew⁶  Nicholas J A Webb⁷ 

[1] Department of Paediatric Nephrology, Great Ormond Street Hospital, London, UK;Department of Paediatric Nephrology, Evelina Children’s Hospital, London, UK;Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK;Children’s Hospital, University Hospitals of Leicester, Leicester, UK;Department of Paediatric Nephrology, Nottingham Children’s Hospital, Nottingham, UK;Health Economics Unit, University of Birmingham, Birmingham, UK;National Institute for Health Research Medicines for Children Research Network Nephrology Clinical Studies Group, UK;Children’s and Academic Renal Unit, University of Bristol, Bristol, UK;Department of Paediatric Nephrology, Birmingham Children’s Hospital, Birmingham, UK

关键词: Health economic analysis;    Adverse effects;    Prednisolone;    Upper respiratory tract infection;    Relapse;    Steroid sensitive nephrotic syndrome;   

Others  :  806650
DOI  :  10.1186/1745-6215-15-147

 received in 2013-10-09, accepted in 2014-04-03,  发布年份 2014

【 摘 要 】

Background

Relapses of childhood steroid-sensitive nephrotic syndrome (SSNS) are treated with a 4- to 8-week course of high-dose oral prednisolone, which may be associated with significant adverse effects. There is a clear association between upper respiratory tract infection (URTI) and relapse development. Previous studies in developing nations have suggested that introducing a 5- to 7-day course of daily prednisolone during an URTI may prevent a relapse developing and the need for a treatment course of high-dose prednisolone. The aim of PREDNOS 2 is to evaluate the effectiveness of a 6-day course of daily prednisolone therapy during an URTI in reducing the development of a subsequent relapse in a developed nation.

Methods/design

The subjects will be 300 children with relapsing SSNS (≥2 relapses in preceding year), who will be randomised to receive either a 6-day course of daily prednisolone or no change to their current therapy (with the use of placebo to double blind) each time they develop an URTI over 12 months. A strict definition for URTI will be used. Subjects will be reviewed at 3, 6, 9 and 12 months to capture data regarding relapse history, ongoing therapy and adverse effect profile, including behavioural problems and quality of life. A formal health economic analysis will also be performed. The primary end point of the study will be the incidence of URTI-related relapse (3 days of Albustix +++) following the first infection during the 12-month follow-up period. DNA and RNA samples will be collected to identify a potential genetic cause for the disease. Subjects will be recruited from over 100 UK centres with the assistance of the Medicines for Children Research Network.

PREDNOS 2 is funded by the National Institute for Health Research Health Technology Assessment Programme (11/129/261).

Discussion

We propose that PREDNOS 2 will be a pivotal study that will inform the future standard of care for children with SSNS. If it is possible to reduce the disease relapse rate effectively and safely, this will reduce the morbidity and cost associated with drug treatment, notwithstanding hospital admission and parental absence from employment.

Trial registration

Current Controlled Trials (ISRCTN10900733).

【 授权许可】

   
2014 Webb et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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