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

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

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Local EPrints ID: 421500
URI: http://eprints.soton.ac.uk/id/eprint/421500
ISSN: 1366-5278
PURE UUID: 5aa6dddc-a24b-4558-9679-e57da60f4fd3
ORCID for Paul Little: ORCID iD orcid.org/0000-0003-3664-1873

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Date deposited: 14 Jun 2018 16:30
Last modified: 12 Jul 2024 01:35

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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 ORCID iD
Author: Anthony Timoney
Author: James N’Dow
Author: Heather Armstrong
Author: Nicola Morris
Author: Kerry Walker
Author: Nikesh Thiruchelvam

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