Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Radboud University
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development