Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.
Summary
This study aims to assess the effectiveness and cost-effectiveness of rectal swab culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal prostate biopsy. Half of participants will receive routine empirical prophylaxis with oral ciprofloxacin (control group), while the other half will receive rectal culture-guided oral antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis, comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative oral antibiotic based on the culture results will be prescribed (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin). The investigators hypothesise that the targeted prophylaxis group (intervention group) will have a lower rate of post-biopsy infectious complications compared to the control group.
Timeline
- Start
- 2018-04-03
- Primary completion
- 2021-09-26
- Completion
- 2021-09-26
Publications
- Tops SCM, Kolwijck E, Koldewijn EL, Somford DM, Delaere FJM, van Leeuwen MA, Breeuwsma AJ, de Vocht TF, Broos HJHP, Schipper RA, Steffens MG, Wegdam-Blans MCA, de Brauwer E, van den Bijllaardt W, Leenders ACAP, Sedelaar JPM, Wertheim HFL, Adang E. Cost Effectiveness of Rectal Culture-based Antibiotic Prophylaxis in Transrectal Prostate Biopsy: The Results from a Randomized, Nonblinded, Multicenter Trial. Eur Urol Open Sci. 2023 Feb 26;50:70-77. doi: 10.1016/j.euros.2023.02.006. eCollection 2023 Apr.
- Tops SCM, Kolwijck E, Koldewijn EL, Somford DM, Delaere FJM, van Leeuwen MA, Breeuwsma AJ, de Vocht TF, Broos HJHP, Schipper RA, Steffens MG, Teerenstra S, Wegdam-Blans MCA, de Brauwer E, van den Bijllaardt W, Leenders ACAP, Sedelaar JPM, Wertheim HFL. Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial. Clin Infect Dis. 2023 Apr 3;76(7):1188-1196. doi: 10.1093/cid/ciac913.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 500 mg | Oral |
| Subject | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Subject | Fosfomycin | Small molecule | 3 g | Oral |
| Subject | Pivmecillinam | Small molecule | 400 mg | Oral |
| Subject | Trimethoprim/Sulfamethoxazole | Unknown | 960 mg | Oral |