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

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

doi:10.1186/s13063-016-1389-y

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

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 HarrisonHeather Armstrong, Elaine McColl, Robert Pickard

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	276
Pages (from-to)	1-18
Number of pages	18
Journal	Trials
Volume	17
DOIs	https://doi.org/10.1186/s13063-016-1389-y
Publication status	Published - 4 Jun 2016

Bibliographical note

Funder statement
This article/paper/report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the UK Government’s Department of Health.

Acknowledgements

We would like to acknowledge Dr Graeme MacLennan, Mr Simon Skene, Mr Julian Shah and Dr Nadine Dougall (past member) for their valuable contribution to the study as DMC members. We would like to thank Professor Chris Butler, Dr Emma Hall, Mr Roland Morley, Mr Dan Wood, Ms Jane Laws and Ms Sarah Bittlestone for their oversight of the AnTIC study as members of the TSC, and we would like to thank Ms Heather Armstrong for her contributions as a patient group representative. We thank all Principal Investigators and site staff for their commitment in recruitment for the AnTIC study. Finally, we would like to thank Hazel Wilde for secretarial support.

The trial is funded by the NIHR Health Technology Assessment Programme (project reference: 11-72-01) and will be published in full in the Health Technology Assessment journal series. The authors also acknowledge the support of the National Institute for Health Research through the Comprehensive Clinical Research Network.

Keywords

self-catheterisation
antibiotic prophylaxis
urinary tract infection
randomised controlled trial
antibiotic resistance
UTI
RCT

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Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study)
© 2016 Brennand et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
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Brennand, C., von Wilamowitz-Moellendorff, A., Dunn, S., Wilkinson, J., Chadwick, T., Ternent, L., Oluboyede, Y., Wood, R., Walton, K., Fader, M., N'Dow, J., Abdel-Fattah, M., McClurg, D., Little, P., Hilton, P., Timoney, A., Morris, N., Thiruchelvam, N., Larcombe, J., ... Pickard, R. (2016). Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial. Trials, 17, 1-18. Article 276. https://doi.org/10.1186/s13063-016-1389-y

Brennand, C, von Wilamowitz-Moellendorff, A, Dunn, S, Wilkinson, J, Chadwick, T, Ternent, L, Oluboyede, Y, Wood, R, Walton, K, Fader, M, N'Dow, J , Abdel-Fattah, M, McClurg, D, Little, P, Hilton, P, Timoney, A, Morris, N, Thiruchelvam, N, Larcombe, J, Harrison, S, Armstrong, H, McColl, E & Pickard, R 2016, 'Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial', Trials, vol. 17, 276, pp. 1-18. https://doi.org/10.1186/s13063-016-1389-y

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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.",

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

note = "Funder statement This article/paper/report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the UK Government{\textquoteright}s Department of Health. Acknowledgements We would like to acknowledge Dr Graeme MacLennan, Mr Simon Skene, Mr Julian Shah and Dr Nadine Dougall (past member) for their valuable contribution to the study as DMC members. We would like to thank Professor Chris Butler, Dr Emma Hall, Mr Roland Morley, Mr Dan Wood, Ms Jane Laws and Ms Sarah Bittlestone for their oversight of the AnTIC study as members of the TSC, and we would like to thank Ms Heather Armstrong for her contributions as a patient group representative. We thank all Principal Investigators and site staff for their commitment in recruitment for the AnTIC study. Finally, we would like to thank Hazel Wilde for secretarial support. The trial is funded by the NIHR Health Technology Assessment Programme (project reference: 11-72-01) and will be published in full in the Health Technology Assessment journal series. The authors also acknowledge the support of the National Institute for Health Research through the Comprehensive Clinical Research Network.",

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T2 - Study protocol for a randomised controlled trial

AU - Brennand, Catherine

AU - von Wilamowitz-Moellendorff, Alexander

AU - Dunn, Sarah

AU - Wilkinson, Jennifer

AU - Chadwick, Thomas

AU - Ternent, Laura

AU - Oluboyede, Yemi

AU - Wood, Ruth

AU - Walton, Katherine

AU - Fader, Mandy

AU - N'Dow, James

AU - Abdel-Fattah, Mohamed

AU - McClurg, Doreen

AU - Little, Paul

AU - Hilton, Paul

AU - Timoney, Anthony

AU - Morris, Nicola

AU - Thiruchelvam, Nikesh

AU - Larcombe, James

AU - Harrison, Simon

AU - Armstrong, Heather

AU - McColl, Elaine

AU - Pickard, Robert

N1 - Funder statement This article/paper/report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the UK Government’s Department of Health. Acknowledgements We would like to acknowledge Dr Graeme MacLennan, Mr Simon Skene, Mr Julian Shah and Dr Nadine Dougall (past member) for their valuable contribution to the study as DMC members. We would like to thank Professor Chris Butler, Dr Emma Hall, Mr Roland Morley, Mr Dan Wood, Ms Jane Laws and Ms Sarah Bittlestone for their oversight of the AnTIC study as members of the TSC, and we would like to thank Ms Heather Armstrong for her contributions as a patient group representative. We thank all Principal Investigators and site staff for their commitment in recruitment for the AnTIC study. Finally, we would like to thank Hazel Wilde for secretarial support. The trial is funded by the NIHR Health Technology Assessment Programme (project reference: 11-72-01) and will be published in full in the Health Technology Assessment journal series. The authors also acknowledge the support of the National Institute for Health Research through the Comprehensive Clinical Research Network.

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N2 - 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.

AB - 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.

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KW - antibiotic prophylaxis

KW - urinary tract infection

KW - randomised controlled trial

KW - antibiotic resistance

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KW - RCT

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DO - 10.1186/s13063-016-1389-y

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JO - Trials

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ER -

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

Abstract

Bibliographical note

Keywords

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