REINFORCE Trial Testing Targeted Versus Standard Antibiotic Prophylaxis to Reduce Infection-Related Readmissions After Cystectomy A Multicenter Randomized Study of Individualized Antibiotic Treatment at Ureteral Stent Removal Following Bladder Removal Surgery

What this Trial Is About

The trial focuses on patients undergoing cystectomy, a complex surgery to remove the urinary bladder, which carries a high risk of infection. Researchers are studying whether using antibiotics targeted to bacteria found in the urine after surgery can lower the chance of infections and hospital readmissions compared to the current standard antibiotic treatment. This Phase 4 trial addresses the lack of clear evidence on the best antibiotic approach after cystectomy and aims to improve patient recovery by testing a more personalized strategy. Participants will be randomly assigned to one of two groups after their bladder removal surgery. One group will receive the standard antibiotic treatment of three doses of pivmecillinam 400mg orally. The other group will receive a single-day antibiotic treatment selected based on bacteria found in their urine during their hospital stay; if no bacteria are found, no antibiotics will be given. All participants will otherwise follow usual care before, during, and after surgery according to hospital guidelines. During the study, patients will give urine samples before and after surgery, complete quality of life questionnaires electronically, and be followed for 90 days to monitor infection-related hospital readmissions. Researchers will track complications and readmissions through medical records and questionnaire responses. The main goal is to see if the targeted antibiotics reduce infection-related readmissions within 90 days after surgery compared to the standard treatment.

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