دورية أكاديمية
Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.
| العنوان: | Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial. |
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| المؤلفون: | Tops SCM; Department of Medical Microbiology and Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands., Kolwijck E; Department of Medical Microbiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands., Koldewijn EL; Department of Urology, Catharina Hospital, Eindhoven, The Netherlands., Somford DM; Department of Urology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands., Delaere FJM; Department of Urology, Zuyderland, Heerlen, The Netherlands., van Leeuwen MA; Department of Urology, Bravis, Roosendaal, The Netherlands., Breeuwsma AJ; ETZ hospital, Tilburg, The Netherlands., de Vocht TF; Department of Urology, Bernhoven, Uden, The Netherlands., Broos HJHP; Department of Urology, Amphia, Breda, The Netherlands., Schipper RA; Department of Urology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands., Steffens MG; Department of Urology, Isala, Zwolle, The Netherlands., Teerenstra S; Department for Health Evidence, Section Biostatistics, Radboud University Medical Center, Nijmegen, The Netherlands., Wegdam-Blans MCA; Department of Medical Microbiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands., de Brauwer E; Department of Medical Microbiology, Zuyderland, Heerlen, The Netherlands., van den Bijllaardt W; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, The Netherlands., Leenders ACAP; Department of Medical Microbiology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands., Sedelaar JPM; Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands., Wertheim HFL; Department of Medical Microbiology and Radboudumc Center for Infectious Diseases, Radboud University Medical Center, Nijmegen, The Netherlands. |
| المصدر: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2023 Apr 03; Vol. 76 (7), pp. 1188-1196. |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Jan. 2011- : Oxford : Oxford University Press Original Publication: Chicago, IL : The University of Chicago Press, c1992- |
| مواضيع طبية MeSH: | Prostate*/diagnostic imaging , Prostate*/pathology , Antibiotic Prophylaxis*/methods, Male ; Humans ; Ultrasonography, Interventional/methods ; Rectum/microbiology ; Biopsy/adverse effects ; Ciprofloxacin/therapeutic use ; Anti-Bacterial Agents/therapeutic use ; Image-Guided Biopsy/methods |
| مستخلص: | 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. Competing Interests: Potential conflicts of interest. D. M. S. reports grants or contracts from Besins and Astellas; payment for expert testimony from Bayer, Janssen, and MSD; a leadership or fiduciary role with the Dutch Urological Association; and receipt of equipment, materials, drugs, medical writing, gifts, or other services from Samantree and Besins. The other authors reported no conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.) |
| التعليقات: | Comment in: Nat Rev Urol. 2023 Feb;20(2):63. (PMID: 36481923) |
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| فهرسة مساهمة: | Keywords: culture-based antibiotic prophylaxis; empirical antibiotic prophylaxis; infectious complications; transrectal prostate biopsy |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03228108 |
| المشرفين على المادة: | 5E8K9I0O4U (Ciprofloxacin) 0 (Anti-Bacterial Agents) |
| تواريخ الأحداث: | Date Created: 20221124 Date Completed: 20230405 Latest Revision: 20230411 |
| رمز التحديث: | 20230411 |
| مُعرف محوري في PubMed: | PMC10069853 |
| DOI: | 10.1093/cid/ciac913 |
| PMID: | 36419331 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1537-6591 |
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| DOI: | 10.1093/cid/ciac913 |