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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial

Authors: Catherine Brennand, Alexander von Wilamowitz-Moellendorff, Sarah Dunn, Jennifer Wilkinson, Thomas Chadwick, Laura Ternent, Yemi Oluboyede, Ruth Wood, Katherine Walton, Mandy Fader, James N’Dow, Mohamed Abdel-Fattah, Doreen McClurg, Paul Little, Paul Hilton, Anthony Timoney, Nicola Morris, Nikesh Thiruchelvam, James Larcombe, Simon Harrison, Heather Armstrong, Elaine McColl, Robert Pickard

Published in: Trials | Issue 1/2016

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Abstract

Background

Clean intermittent self-catheterisation is an important management option for people who cannot empty their bladder effectively. Recurrent urinary tract infections are common in these patients. Data from recent studies suggest that antibiotic prophylaxis may be beneficial in reducing infection risk, but the effectiveness of this intervention remains uncertain.

Methods/design

This is a 52-site, patient randomised superiority trial set in routine care comparing an experimental strategy of once daily antibiotic prophylaxis for 12 months against a control strategy of no prophylaxis in people who carry out self-catheterisation and suffer recurrent urinary tract infections. The primary outcome is number of urinary tract infections during a 12-month treatment period. Both groups will otherwise receive usual care including on demand treatment courses of antibiotics for urinary tract infection. Participants and their clinicians will not be blinded to the allocated intervention, but central trial staff managing and analysing trial data will, as far as possible, be unaware of participant allocation. The analysis will follow intention-to-treat principles.

Discussion

This trial was commissioned and funded by the United Kingdom National Health Service following prioritisation of the research question by the National Institute for Health and Care Excellence.

Trial registration

ISRCTN67145101 EUDRACT2013-002556-32. Registered on 25 October 2013.
Appendix
Available only for authorised users
Footnotes
1
The definition chosen was the laboratory report of one or two isolates of a uropathogen at ≥105 cfu/mL or a single isolate at ≥104 cfu/mL in a symptomatic participant [22]. The central laboratory result will be used preferentially for this outcome with the local result used only if a suitable sample was not received by the central laboratory.
 
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Metadata
Title
Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial
Authors
Catherine Brennand
Alexander von Wilamowitz-Moellendorff
Sarah Dunn
Jennifer Wilkinson
Thomas Chadwick
Laura Ternent
Yemi Oluboyede
Ruth Wood
Katherine Walton
Mandy Fader
James N’Dow
Mohamed Abdel-Fattah
Doreen McClurg
Paul Little
Paul Hilton
Anthony Timoney
Nicola Morris
Nikesh Thiruchelvam
James Larcombe
Simon Harrison
Heather Armstrong
Elaine McColl
Robert Pickard
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1389-y

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