The University of Southampton
University of Southampton Institutional Repository

Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: The AnTIC RCT

Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: The AnTIC RCT
Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: The AnTIC RCT

Background: People carrying out clean intermittent self-catheterisation (CISC) to empty their bladder often suffer repeated urinary tract infections (UTIs). Continuous once-daily, low-dose antibiotic treatment (antibiotic prophylaxis) is commonly advised but knowledge of its effectiveness is lacking. Objective: To assess the benefit, harms and cost-effectiveness of antibiotic prophylaxis to prevent UTIs in people who perform CISC. Design: Parallel-group, open-label, patient-randomised 12-month trial of allocated intervention with 3-monthly follow-up. Outcome assessors were blind to allocation. Setting: UK NHS, with recruitment of patients from 51 sites. Participants: Four hundred and four adults performing CISC and predicted to continue for ≥ 12 months who had suffered at least two UTIs in the previous year or had been hospitalised for a UTI in the previous year. Interventions: A central randomisation system using random block allocation set by an independent statistician allocated participants to the experimental group [once-daily oral antibiotic prophylaxis using either 50 mg of nitrofurantoin, 100 mg of trimethoprim (Kent Pharmaceuticals, Ashford, UK) or 250 mg of cefalexin (Sandoz Ltd, Holzkirchen, Germany); n = 203] or the control group of no prophylaxis (n = 201), both for 12 months. Main outcome measures: The primary clinical outcome was relative frequency of symptomatic, antibiotic-treated UTI. Cost-effectiveness was assessed by cost per UTI avoided. The secondary measures were microbiologically proven UTI, antimicrobial resistance, health status and participants’ attitudes to antibiotic use. Results: The frequency of symptomatic antibiotic-treated UTI was reduced by 48% using prophylaxis [incidence rate ratio (IRR) 0.52, 95% confidence interval (CI) 0.44 to 0.61; n = 361]. Reduction in microbiologically proven UTI was similar (IRR 0.49, 95% CI 0.39 to 0.60; n = 361). Absolute reduction in UTI episodes over 12 months was from a median (interquartile range) of 2 (1-4) in the no-prophylaxis group (n = 180) to 1 (0-2) in the prophylaxis group (n = 181). The results were unchanged by adjustment for days at risk of UTI and the presence of factors giving higher risk of UTI. Development of antimicrobial resistance was seen more frequently in pathogens isolated from urine and Escherichia coli from perianal swabs in participants allocated to antibiotic prophylaxis. The use of prophylaxis incurred an extra cost of £99 to prevent one UTI (not including costs related to increased antimicrobial resistance). The emotional and practical burden of CISC and UTI influenced well-being, but health status measured over 12 months was similar between groups and did not deteriorate significantly during UTI. Participants were generally unconcerned about using antibiotics, including the possible development of antimicrobial resistance. Limitations: Lack of blinding may have led participants in each group to use different thresholds to trigger reporting and treatment-seeking for UTI. Conclusions: The results of this large randomised trial, conducted in accordance with best practice, demonstrate clear benefit for antibiotic prophylaxis in terms of reducing the frequency of UTI for people carrying out CISC. Antibiotic prophylaxis use appears safe for individuals over 12 months, but the emergence of resistant urinary pathogens may prejudice longer-term management of recurrent UTI and is a public health concern. Future work includes longer-term studies of antimicrobial resistance and studies of non-antibiotic preventative strategies.

1366-5278
1-102
Pickard, Robert
f2df6ef4-1759-48e1-982b-46f2d1c08a45
Chadwick, Thomas
676ec91d-ae13-4d82-8838-c0b7b8848d92
Oluboyede, Yemi
15b53f18-a367-4b8d-bc53-615c433a998b
Brennand, Catherine
b7a2d068-9066-4d40-bc98-a98504a04486
Von Wilamowitz-Moellendorff, Alexander
ef7681f8-030b-4de3-87d7-1466a03b56e1
McClurg, Doreen
6a540653-5dc0-4815-89ab-5a40ddde1fea
Wilkinson, Jennifer
5cd0aa54-4ba7-4659-8ee4-e68ea750fd75
Ternent, Laura
aa0c0473-08b0-4497-9708-639cefc36a6b
Fisher, Holly
ae099ea0-3b83-4509-86c5-d2c5d5d27168
Walton, Katherine
724131c7-e7b5-4835-bfcf-424747365ec2
McColl, Elaine
b5c9e36a-5e70-489e-bb6e-a84180e1c9d4
Vale, Luke
d0be6b50-51db-4d59-9094-17dcb5582bd8
Wood, Ruth
fb4e06da-316d-44b0-a412-dc9c5cd66f73
Abdel-Fattah, Mohamed
5531cad3-00fa-4ec9-9664-d1e64467d5fc
Hilton, Paul
51ecbb11-f1fa-4c0d-8aeb-734883a8e28e
Fader, Mandy
c318f942-2ddb-462a-9183-8b678faf7277
Harrison, Simon
1290a8d9-bb7a-442d-9356-f677e0ca4a9a
Larcombe, James
1d3789d7-71c8-426d-b667-4b0e26a752eb
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Timoney, Anthony
37f4c0da-1ce0-41fc-8adb-e7b00b1b6a59
N’Dow, James
fb603b5a-811b-459a-8eb9-2603e4b31ed7
Armstrong, Heather
f1d51b92-ce8e-4be8-8243-37f3eaf26c63
Morris, Nicola
21c7fb9f-b3fb-4073-bc31-90c83ada3856
Walker, Kerry
69fa1887-9580-4533-8fae-b906a4186f96
Thiruchelvam, Nikesh
048516f8-98d8-4cf0-854d-b7f90cb4a2c7
Pickard, Robert
f2df6ef4-1759-48e1-982b-46f2d1c08a45
Chadwick, Thomas
676ec91d-ae13-4d82-8838-c0b7b8848d92
Oluboyede, Yemi
15b53f18-a367-4b8d-bc53-615c433a998b
Brennand, Catherine
b7a2d068-9066-4d40-bc98-a98504a04486
Von Wilamowitz-Moellendorff, Alexander
ef7681f8-030b-4de3-87d7-1466a03b56e1
McClurg, Doreen
6a540653-5dc0-4815-89ab-5a40ddde1fea
Wilkinson, Jennifer
5cd0aa54-4ba7-4659-8ee4-e68ea750fd75
Ternent, Laura
aa0c0473-08b0-4497-9708-639cefc36a6b
Fisher, Holly
ae099ea0-3b83-4509-86c5-d2c5d5d27168
Walton, Katherine
724131c7-e7b5-4835-bfcf-424747365ec2
McColl, Elaine
b5c9e36a-5e70-489e-bb6e-a84180e1c9d4
Vale, Luke
d0be6b50-51db-4d59-9094-17dcb5582bd8
Wood, Ruth
fb4e06da-316d-44b0-a412-dc9c5cd66f73
Abdel-Fattah, Mohamed
5531cad3-00fa-4ec9-9664-d1e64467d5fc
Hilton, Paul
51ecbb11-f1fa-4c0d-8aeb-734883a8e28e
Fader, Mandy
c318f942-2ddb-462a-9183-8b678faf7277
Harrison, Simon
1290a8d9-bb7a-442d-9356-f677e0ca4a9a
Larcombe, James
1d3789d7-71c8-426d-b667-4b0e26a752eb
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Timoney, Anthony
37f4c0da-1ce0-41fc-8adb-e7b00b1b6a59
N’Dow, James
fb603b5a-811b-459a-8eb9-2603e4b31ed7
Armstrong, Heather
f1d51b92-ce8e-4be8-8243-37f3eaf26c63
Morris, Nicola
21c7fb9f-b3fb-4073-bc31-90c83ada3856
Walker, Kerry
69fa1887-9580-4533-8fae-b906a4186f96
Thiruchelvam, Nikesh
048516f8-98d8-4cf0-854d-b7f90cb4a2c7

Pickard, Robert, Chadwick, Thomas, Oluboyede, Yemi, Brennand, Catherine, Von Wilamowitz-Moellendorff, Alexander, McClurg, Doreen, Wilkinson, Jennifer, Ternent, Laura, Fisher, Holly, Walton, Katherine, McColl, Elaine, Vale, Luke, Wood, Ruth, Abdel-Fattah, Mohamed, Hilton, Paul, Fader, Mandy, Harrison, Simon, Larcombe, James, Little, Paul, Timoney, Anthony, N’Dow, James, Armstrong, Heather, Morris, Nicola, Walker, Kerry and Thiruchelvam, Nikesh (2018) Continuous low-dose antibiotic prophylaxis to prevent urinary tract infection in adults who perform clean intermittent self-catheterisation: The AnTIC RCT. Health Technology Assessment, 22 (24), 1-102. (doi:10.3310/hta22240).

Record type: Article

Abstract

Background: People carrying out clean intermittent self-catheterisation (CISC) to empty their bladder often suffer repeated urinary tract infections (UTIs). Continuous once-daily, low-dose antibiotic treatment (antibiotic prophylaxis) is commonly advised but knowledge of its effectiveness is lacking. Objective: To assess the benefit, harms and cost-effectiveness of antibiotic prophylaxis to prevent UTIs in people who perform CISC. Design: Parallel-group, open-label, patient-randomised 12-month trial of allocated intervention with 3-monthly follow-up. Outcome assessors were blind to allocation. Setting: UK NHS, with recruitment of patients from 51 sites. Participants: Four hundred and four adults performing CISC and predicted to continue for ≥ 12 months who had suffered at least two UTIs in the previous year or had been hospitalised for a UTI in the previous year. Interventions: A central randomisation system using random block allocation set by an independent statistician allocated participants to the experimental group [once-daily oral antibiotic prophylaxis using either 50 mg of nitrofurantoin, 100 mg of trimethoprim (Kent Pharmaceuticals, Ashford, UK) or 250 mg of cefalexin (Sandoz Ltd, Holzkirchen, Germany); n = 203] or the control group of no prophylaxis (n = 201), both for 12 months. Main outcome measures: The primary clinical outcome was relative frequency of symptomatic, antibiotic-treated UTI. Cost-effectiveness was assessed by cost per UTI avoided. The secondary measures were microbiologically proven UTI, antimicrobial resistance, health status and participants’ attitudes to antibiotic use. Results: The frequency of symptomatic antibiotic-treated UTI was reduced by 48% using prophylaxis [incidence rate ratio (IRR) 0.52, 95% confidence interval (CI) 0.44 to 0.61; n = 361]. Reduction in microbiologically proven UTI was similar (IRR 0.49, 95% CI 0.39 to 0.60; n = 361). Absolute reduction in UTI episodes over 12 months was from a median (interquartile range) of 2 (1-4) in the no-prophylaxis group (n = 180) to 1 (0-2) in the prophylaxis group (n = 181). The results were unchanged by adjustment for days at risk of UTI and the presence of factors giving higher risk of UTI. Development of antimicrobial resistance was seen more frequently in pathogens isolated from urine and Escherichia coli from perianal swabs in participants allocated to antibiotic prophylaxis. The use of prophylaxis incurred an extra cost of £99 to prevent one UTI (not including costs related to increased antimicrobial resistance). The emotional and practical burden of CISC and UTI influenced well-being, but health status measured over 12 months was similar between groups and did not deteriorate significantly during UTI. Participants were generally unconcerned about using antibiotics, including the possible development of antimicrobial resistance. Limitations: Lack of blinding may have led participants in each group to use different thresholds to trigger reporting and treatment-seeking for UTI. Conclusions: The results of this large randomised trial, conducted in accordance with best practice, demonstrate clear benefit for antibiotic prophylaxis in terms of reducing the frequency of UTI for people carrying out CISC. Antibiotic prophylaxis use appears safe for individuals over 12 months, but the emergence of resistant urinary pathogens may prejudice longer-term management of recurrent UTI and is a public health concern. Future work includes longer-term studies of antimicrobial resistance and studies of non-antibiotic preventative strategies.

Text
3014419 (1) - Version of Record
Download (2MB)

More information

Accepted/In Press date: 1 January 2018
e-pub ahead of print date: 1 May 2018
Published date: 1 May 2018

Identifiers

Local EPrints ID: 421500
URI: http://eprints.soton.ac.uk/id/eprint/421500
ISSN: 1366-5278
PURE UUID: 5aa6dddc-a24b-4558-9679-e57da60f4fd3

Catalogue record

Date deposited: 14 Jun 2018 16:30
Last modified: 16 Dec 2019 18:09

Export record

Altmetrics

Contributors

Author: Robert Pickard
Author: Thomas Chadwick
Author: Yemi Oluboyede
Author: Catherine Brennand
Author: Alexander Von Wilamowitz-Moellendorff
Author: Doreen McClurg
Author: Jennifer Wilkinson
Author: Laura Ternent
Author: Holly Fisher
Author: Katherine Walton
Author: Elaine McColl
Author: Luke Vale
Author: Ruth Wood
Author: Mohamed Abdel-Fattah
Author: Paul Hilton
Author: Mandy Fader
Author: Simon Harrison
Author: James Larcombe
Author: Paul Little
Author: Anthony Timoney
Author: James N’Dow
Author: Heather Armstrong
Author: Nicola Morris
Author: Kerry Walker
Author: Nikesh Thiruchelvam

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×