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 | |
| Publication status | Published - 4 Jun 2016 |
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Keywords
- self-catheterisation
- antibiotic prophylaxis
- urinary tract infection
- randomised controlled trial
- antibiotic resistance
- UTI
- RCT
Cite this
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 journal › Article
}
TY - JOUR
T1 - Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study)
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.
PY - 2016/6/4
Y1 - 2016/6/4
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.
KW - self-catheterisation
KW - antibiotic prophylaxis
KW - urinary tract infection
KW - randomised controlled trial
KW - antibiotic resistance
KW - UTI
KW - RCT
U2 - 10.1186/s13063-016-1389-y
DO - 10.1186/s13063-016-1389-y
M3 - Article
C2 - 27259552
VL - 17
SP - 1
EP - 18
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 276
ER -