Evidence map›Paper›PMID 36419331›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023

Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.

Sofie C M Tops, Eva Kolwijck, Evert L Koldewijn, Diederik M Somford, Filip J M Delaere, Menno A van Leeuwen, Anthonius J Breeuwsma, Thijn F de Vocht, Hans J H P Broos, Rob A Schipper and 8 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03228108 (The Effect of Rectal Swab Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy on Infectious Complications and Cost of Care), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.6field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03228108 phase4completednot on this map

The Effect of Rectal Swab Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy on Infectious Complications and Cost of Care: A Randomized Controlled Trial in the Netherlands.

TypeinterventionalSponsorRadboud University Medical CenterRan2018 to 2021Enrolled1,538ConditionsComplication, Infection, Prostate CancerArmsCiprofloxacin, Trimethoprim/Sulfamethoxazole, Fosfomycin, Pivmecillinam/augmentin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 25 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Impact of Approach Routes in MRI-Ultrasound Fusion Prostate Biopsy on Post-Biopsy Complications: A Propensity Score-Matched Analysis.International journal of urology : official journal of the Japanese Urological Association · 2026
    Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 1 country.

Sofie C M TopsDepartment of Medical Microbiology and Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Eva KolwijckDepartment of Medical Microbiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Evert L KoldewijnDepartment of Urology, Catharina Hospital, Eindhoven, The Netherlands.
Diederik M SomfordDepartment of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.
Filip J M DelaereDepartment of Urology, Zuyderland, Heerlen, The Netherlands.
Menno A van LeeuwenDepartment of Urology, Bravis, Roosendaal, The Netherlands.
Anthonius J BreeuwsmaETZ hospital, Tilburg, The Netherlands.
Thijn F de VochtDepartment of Urology, Bernhoven, Uden, The Netherlands.
Hans J H P BroosDepartment of Urology, Amphia, Breda, The Netherlands.
Rob A SchipperDepartment of Urology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
Martijn G SteffensDepartment of Urology, Isala, Zwolle, The Netherlands.
Steven TeerenstraDepartment for Health Evidence, Section Biostatistics, Radboud University Medical Center, Nijmegen, The Netherlands.
Marjolijn C A Wegdam-BlansDepartment of Medical Microbiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Els de BrauwerDepartment of Medical Microbiology, Zuyderland, Heerlen, The Netherlands.
Wouter van den BijllaardtMicrovida Laboratory for Medical Microbiology, Amphia Hospital, Breda, The Netherlands.
Alexander C A P LeendersDepartment of Medical Microbiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
J P Michiel SedelaarDepartment of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
Heiman F L WertheimDepartment of Medical Microbiology and Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands.
Jeroen Bosch Ziekenhuis · NLAmphia Ziekenhuis · NLRadboud University Medical Center · NLRadboud University Nijmegen · NLZuyderland Medisch Centrum · NLBravis Ziekenhuis · NLCanisius-Wilhelmina Ziekenhuis · NLCatharina Ziekenhuis · NLElisabeth-TweeSteden Ziekenhuis · NLIsala · NLUtrecht University · NLZiekenhuis Bernhoven · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAn increase in infections after transrectal prostate biopsy (PB), related to an increasing number of patients with ciprofloxacin-resistant rectal flora, necessitates the exploration of alternatives for the traditionally used empirical prophylaxis of ciprofloxacin. We compared infectious complication rates after transrectal PB using empirical ciprofloxacin prophylaxis versus culture-based prophylaxis.

methodsIn this nonblinded, randomized trial, between 4 April 2018 and 30 July 2021, we enrolled 1538 patients from 11 Dutch hospitals undergoing transrectal PB. After rectal swab collection, patients were randomized 1:1 to receive empirical prophylaxis with oral ciprofloxacin (control group [CG]) or culture-based prophylaxis (intervention group [IG]). Primary outcome was any infectious complication within 7 days after biopsy. Secondary outcomes were infectious complications within 30 days, and bacteremia and bacteriuria within 7 and 30 days postbiopsy. For primary outcome analysis, the χ2 test stratified for hospitals was used. Trial registration number: NCT03228108.

resultsData from 1288 patients (83.7%) were available for analysis (CG, 652; IG, 636). Infection rates within 7 days postbiopsy were 4.3% (n = 28) (CG) and 2.5% (n = 16) (IG) (P value = .08; reduction: -1.8%; 95% confidence interval, -.004 to .040). Ciprofloxacin-resistant bacteria were detected in 15.2% (n = 1288). In the CG, the presence of ciprofloxacin-resistant rectal flora resulted in a 6.2-fold higher risk of early postbiopsy infection.

conclusionsOur study supports the use of culture-based prophylaxis to reduce infectious complications after transrectal PB. Despite adequate prophylaxis, postbiopsy infections can still occur. Therefore, culture-based prophylaxis must be weighed against other strategies that could reduce postbiopsy infections. Clinical Trials Registration. NCT03228108.

Indexed as

Antibiotic ProphylaxisProstateAnti-Bacterial AgentsBiopsyCiprofloxacinHumansImage-Guided BiopsyMaleRectumUltrasonography, InterventionalAnti-Bacterial AgentsCiprofloxacinculture-based antibiotic prophylaxisempirical antibiotic prophylaxisinfectious complicationstransrectal prostate biopsy

Identifiers

PMID36419331
PMCPMC10069853
OpenAlexW4309844269

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.