Continuous low dose antibiotic prophylaxis for adults performing clean intermittent catheterisation who suffer repeated urinary tract infection (AnTIC): a randomised, open-label, superiority trial

Holly Fisher*, Yemi Oluboyede, Thomas Chadwick, Mohamed Abdel-Fattah, Catherine Brennand, Mandy Fader, Simon Harrison, Paul Hilton, James Larcombe, Paul Little, Doreen McClurg, Elaine McColl, James N’Dow, Laura Ternent, Nikesh Thiruchelvam, Anthony Timoney, Luke Vale, Katherine Walton, Alexander von Wilamowitz-Moellendorff, Jennifer WilkinsonRuth Wood, Robert Pickard

*Corresponding author for this work

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Abstract

Background: Repeated symptomatic urinary tract infection (UTI) affects 25% of people using clean intermittent self-catheterisation (CISC) to empty their bladder. This study aimed to determine benefit, harms and cost-effectiveness of continuous low dose antibiotic prophylaxis for UTI prevention in adult CISC-users. Methods: This randomised, superiority trial, recruited from 51 UK National Health Service organisations between 26/11/2013 and 31/01/2016 (closure). Community users of CISC suffering repeated UTI were randomly allocated 1:1 by an internet-based system using permuted blocks of variable length to receive either antibiotic prophylaxis or no prophylaxis for 12 months. Trial and laboratory staff assessing outcomes were masked to allocation. Primary outcome was frequency of symptomatic, antibiotic-treated UTI over 12 months. Participants completing at least 6 months follow up were assumed to have a reliable estimate of UTI rate and were included in a modified intention-to-treat analysis, with sensitivity analysis performed on a strict intention-to-treat basis. ISRCTN: 67145101, EudraCT: 2013-002556-32.Findings: The primary analysis included 181/203 (89%) adults allocated to prophylaxis and 180/201 (90%) to no prophylaxis. The incidence rate (95% confidence interval) of symptomatic antibiotic-treated UTI over 12 months was 1.3 (1.1-1.6) and 2.6 (2.3-2.9) respectively, with incidence rate ratio of 0¿52 (0¿44 to 0¿61, p <0¿001); a 48% reduction in UTI frequency with prophylaxis. Use of prophylaxis was well-tolerated, with 42 minor adverse events recorded in the prophylaxis group predominantly gastro-intestinal disturbance and candida infection. Resistance against antibiotics used for UTI treatment was more frequent in urinary isolates from the prophylaxis group. Prophylaxis cost an additional £99 to avoid a UTI.Interpretation: Continuous antibiotic prophylaxis is effective in reducing UTI frequency for CISC users. It is acceptable to individuals and likely to be cost-effective. Increased resistance of urinary bacteria will concern patients and healthcare policy-makers. Funding UK National Institute for Health Research
Original languageEnglish
Pages (from-to)957-968
Number of pages12
JournalThe Lancet Infectious Diseases
Volume18
Issue number9
Early online date28 Jun 2018
DOIs
Publication statusPublished - 1 Sep 2018

Keywords

  • antibiotics
  • catheterisation
  • urinary tract infection

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    Fisher, H., Oluboyede, Y., Chadwick, T., Abdel-Fattah, M., Brennand, C., Fader, M., Harrison, S., Hilton, P., Larcombe, J., Little, P., McClurg, D., McColl, E., N’Dow, J., Ternent, L., Thiruchelvam, N., Timoney, A., Vale, L., Walton, K., von Wilamowitz-Moellendorff, A., ... Pickard, R. (2018). Continuous low dose antibiotic prophylaxis for adults performing clean intermittent catheterisation who suffer repeated urinary tract infection (AnTIC): a randomised, open-label, superiority trial. The Lancet Infectious Diseases, 18(9), 957-968. https://doi.org/10.1016/S1473-3099(18)30279-2