Clinical Trial

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Study acronym: REINFORCE
Recruiting Phase 4
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Summary
The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis. Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively. The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-11-27; most recent amendment 2025-01-08.
Status change: Not Yet Recruiting → Recruiting 2025-01-08
Trial Details
NCT Number NCT06709196
Lead Sponsor Rigshospitalet, Denmark
Conditions Cystectomy, Bladder Cancer Requiring Cystectomy, Postoperative Infections, Antibiotic Prophylaxis, Ileal Conduit
Enrollment 248 participants
Start Date 2025-01-07
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-09