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

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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 languageEnglish
Article number276
Pages (from-to)1-18
Number of pages18
JournalTrials
Volume17
DOIs
Publication statusPublished - 4 Jun 2016

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Urinary Tract Infections
Catheterization
Urinary Bladder
Randomized Controlled Trials
Anti-Bacterial Agents
Antibiotic Prophylaxis
Intermittent Urethral Catheterization
National Institutes of Health (U.S.)
National Health Programs
Therapeutics
Delivery of Health Care
Infection
Research

Keywords

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

Cite this

Brennand, C., von Wilamowitz-Moellendorff, A., Dunn, S., Wilkinson, J., Chadwick, T., Ternent, L., ... 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. [276]. https://doi.org/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. / Brennand, Catherine; von Wilamowitz-Moellendorff, Alexander; Dunn, Sarah; Wilkinson, Jennifer; Chadwick, Thomas; Ternent, Laura; Oluboyede, Yemi; Wood, Ruth; Walton, Katherine; Fader, Mandy; N'Dow, James; Abdel-Fattah, Mohamed; McClurg, Doreen; Little, Paul; Hilton, Paul; Timoney, Anthony; Morris, Nicola; Thiruchelvam, Nikesh; Larcombe, James; Harrison, Simon; Armstrong, Heather; McColl, Elaine; Pickard, Robert.

In: Trials, Vol. 17, 276, 04.06.2016, p. 1-18.

Research output: Contribution to journalArticle

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
Brennand, Catherine ; von Wilamowitz-Moellendorff, Alexander ; Dunn, Sarah ; Wilkinson, Jennifer ; Chadwick, Thomas ; Ternent, Laura ; Oluboyede, Yemi ; Wood, Ruth ; Walton, Katherine ; Fader, Mandy ; N'Dow, James ; Abdel-Fattah, Mohamed ; McClurg, Doreen ; Little, Paul ; Hilton, Paul ; Timoney, Anthony ; Morris, Nicola ; Thiruchelvam, Nikesh ; Larcombe, James ; Harrison, Simon ; Armstrong, Heather ; McColl, Elaine ; Pickard, Robert. / Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study) : Study protocol for a randomised controlled trial. In: Trials. 2016 ; Vol. 17. pp. 1-18.
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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",
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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

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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.

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KW - UTI

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