학술논문
Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.
Document Type
Article
Author
Tops, Sofie C M; Kolwijck, Eva; Koldewijn, Evert L; Somford, Diederik M; Delaere, Filip J M; Leeuwen, Menno A van; Breeuwsma, Anthonius J; Vocht, Thijn F de; Broos, Hans J H P; Schipper, Rob A; Steffens, Martijn G; Teerenstra, Steven; Wegdam-Blans, Marjolijn C A; Brauwer, Els de; van den Bijllaardt, Wouter; Leenders, Alexander C A P; Sedelaar, J P Michiel; Wertheim, Heiman F L
Source
Subject
*INFECTION prevention
*RESEARCH
*STATISTICS
*BIOPSY
*CONFIDENCE intervals
*PROSTATE
*ANTIBIOTIC prophylaxis
*TREATMENT effectiveness
*RANDOMIZED controlled trials
*RESEARCH funding
*DESCRIPTIVE statistics
*CHI-squared test
*DATA analysis software
*DATA analysis
*ODDS ratio
*LOGISTIC regression analysis
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
Language
ISSN
1058-4838
Abstract
Background An 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. Methods In 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. Results Data 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. Conclusions Our 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. [ABSTRACT FROM AUTHOR]