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Fosfomycin versus ciprofloxacin for transrectal prostate biopsy : An open randomised controlled multicentre drug trial

Anders, Andreasson ; Anita, Hällgren ; Petros, Georgeoulas ; Jon, Forsberg ; Jon, Fridriksson ; Gabriel, Granåsen ; Karl-Johan, Lundström ; Sven, Resare ; Beatrice, Backman Lönn and Magnus, Grabe LU , et al. (2025) In Journal of Clinical Urology
Abstract

Objective: Antibiotic prophylaxis reduces infection risk following transrectal prostate biopsy. Studies in countries with high antibiotic resistance show that fosfomycin, given an hour or more before biopsy, has equal or better outcomes than ciprofloxacin. This study aimed to evaluate if fosfomycin, administered immediately before biopsy, is as effective as ciprofloxacin in Sweden, where antibiotic resistance is low. Material and Methods: A randomised, non-inferiority study of different antibiotic prophylactic regimes, including men undergoing transrectal prostate biopsy, was conducted. A total of 3448 patients were planned to be included. Primary outcome was hospitalisation due to urinary tract infection (UTI) within 14 days. Men... (More)

Objective: Antibiotic prophylaxis reduces infection risk following transrectal prostate biopsy. Studies in countries with high antibiotic resistance show that fosfomycin, given an hour or more before biopsy, has equal or better outcomes than ciprofloxacin. This study aimed to evaluate if fosfomycin, administered immediately before biopsy, is as effective as ciprofloxacin in Sweden, where antibiotic resistance is low. Material and Methods: A randomised, non-inferiority study of different antibiotic prophylactic regimes, including men undergoing transrectal prostate biopsy, was conducted. A total of 3448 patients were planned to be included. Primary outcome was hospitalisation due to urinary tract infection (UTI) within 14 days. Men without risk factors for infection received either fosfomycin or ciprofloxacin immediately before biopsy. Patients with risk factors received additional doses post-biopsy. Results: The study was stopped by the safety board after enrolment of 42 men. Four of 20 men (25%) in the fosfomycin group were hospitalised due to UTI, including two with positive blood cultures for Pseudomonas, whereas no hospitalisations (0%) occurred in the ciprofloxacin group. The main limitation was the small sample size. Conclusion: Fosfomycin administered immediately before biopsy was not supported by this study. The results may be skewed by the high incidence of Pseudomonas infections.

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type
Contribution to journal
publication status
epub
subject
keywords
antibiotic prophylaxis, fosfomycin, prostate, Prostate biopsy, prostate cancer, urological infections
in
Journal of Clinical Urology
article number
20514158251376398
publisher
SAGE Publications
external identifiers
  • scopus:105019244608
ISSN
2051-4158
DOI
10.1177/20514158251376398
language
English
LU publication?
yes
additional info
Publisher Copyright: © British Association of Urological Surgeons 2025. This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
id
8f2969ff-ff29-4793-afb4-44131cce9969
date added to LUP
2026-01-19 14:53:36
date last changed
2026-01-19 14:54:12
@article{8f2969ff-ff29-4793-afb4-44131cce9969,
  abstract     = {{<p>Objective: Antibiotic prophylaxis reduces infection risk following transrectal prostate biopsy. Studies in countries with high antibiotic resistance show that fosfomycin, given an hour or more before biopsy, has equal or better outcomes than ciprofloxacin. This study aimed to evaluate if fosfomycin, administered immediately before biopsy, is as effective as ciprofloxacin in Sweden, where antibiotic resistance is low. Material and Methods: A randomised, non-inferiority study of different antibiotic prophylactic regimes, including men undergoing transrectal prostate biopsy, was conducted. A total of 3448 patients were planned to be included. Primary outcome was hospitalisation due to urinary tract infection (UTI) within 14 days. Men without risk factors for infection received either fosfomycin or ciprofloxacin immediately before biopsy. Patients with risk factors received additional doses post-biopsy. Results: The study was stopped by the safety board after enrolment of 42 men. Four of 20 men (25%) in the fosfomycin group were hospitalised due to UTI, including two with positive blood cultures for Pseudomonas, whereas no hospitalisations (0%) occurred in the ciprofloxacin group. The main limitation was the small sample size. Conclusion: Fosfomycin administered immediately before biopsy was not supported by this study. The results may be skewed by the high incidence of Pseudomonas infections.</p>}},
  author       = {{Anders, Andreasson and Anita, Hällgren and Petros, Georgeoulas and Jon, Forsberg and Jon, Fridriksson and Gabriel, Granåsen and Karl-Johan, Lundström and Sven, Resare and Beatrice, Backman Lönn and Magnus, Grabe and Pär, Stattin and Johan, Stranne and Martin, Holmbom and Martin, Sundqvist and Johan, Styrke}},
  issn         = {{2051-4158}},
  keywords     = {{antibiotic prophylaxis; fosfomycin; prostate; Prostate biopsy; prostate cancer; urological infections}},
  language     = {{eng}},
  publisher    = {{SAGE Publications}},
  series       = {{Journal of Clinical Urology}},
  title        = {{Fosfomycin versus ciprofloxacin for transrectal prostate biopsy : An open randomised controlled multicentre drug trial}},
  url          = {{http://dx.doi.org/10.1177/20514158251376398}},
  doi          = {{10.1177/20514158251376398}},
  year         = {{2025}},
}