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



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.



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.



ISRCTN67145101 EUDRACT2013-002556-32. Registered on 25 October 2013.
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Catherine
C
Brennand
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK. Alexander.von-Wilamowitz-Moellendorff@newcastle.ac.uk.
Alexander
A
von Wilamowitz-Moellendorff
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Sarah
S
Dunn
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Jennifer
J
Wilkinson
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.|Institute of Health and Society, Baddiley Clark Building, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Thomas
T
Chadwick
Institute of Health and Society, Baddiley Clark Building, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Laura
L
Ternent
Institute of Health and Society, Baddiley Clark Building, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.
Yemi
Y
Oluboyede
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.
Ruth
R
Wood
Department of Medical Microbiology, Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Katherine
K
Walton
University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YDUK, UK.
Mandy
M
Fader
Academic Urology Unit, University of Aberdeen, Health Sciences Building (2nd floor), Foresterhill, Aberdeen, AB25 2ZD, UK.
James
J
N'Dow
Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, UK.
Mohamed
M
Abdel-Fattah
Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Doreen
D
McClurg
University of Southampton, Southampton General Hospital, Tremona Road, Southampton, SO16 6YDUK, UK.|Aldermoor Health Centre, Aldermoor Close, Southampton, SO16 5ST, UK.
Paul
P
Little
The Medical School, Newcastle University, Newcastle upon Tyne, UK.
Paul
P
Hilton
Department of Urology, Southmead Hospital, North Bristol NHS Trust, Bristol, SB10 5NB, UK.
Anthony
A
Timoney
Department of Urology, Southmead Hospital, North Bristol NHS Trust, Bristol, SB10 5NB, UK.
Nicola
N
Morris
Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Hills Road, Cambridge, CB2 0QQ, UK.
Nikesh
N
Thiruchelvam
Harbinson House Surgery, Front Street, Sedgefield, Co Durham, TS21 3BN, UK.
James
J
Larcombe
Mid-Yorkshire NHS Trust, Pinderfields Hospital, Aberford Road, Wakefield, West Yorkshire, WF1 4DG, UK.
Simon
S
Harrison
Patient advisor, Durham, United Kingdom.
Heather
H
Armstrong
Newcastle Clinical Trials Unit, Newcastle University, 1-2 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, UK.|Institute of Health and Society, Baddiley Clark Building, Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK.|The Medical School, Newcastle University, Newcastle upon Tyne, UK.
Elaine
E
McColl
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.|Institute of Cellular Medicine, The Medical School, Newcastle University, 3rd Floor, William Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.
Robert
R
Pickard
D019072:Antibiotic Prophylaxis; D002985:Clinical Protocols; D003625:Data Collection; D006801:Humans; D055118:Medication Adherence; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D014546:Urinary Catheterization / Q000009:adverse effects*; D014552:Urinary Tract Infections / Q000517:prevention & control*
Antibiotic prophylaxis; RCT; Randomised controlled trial; Self-catheterisation; UTI; Urinary tract infection; antibiotic resistance