RecruitingPhase 4NCT06709196

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

REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.

Sponsor

Rigshospitalet, Denmark

Enrollment

248 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Ileal Conduit Cystectomy Bladder Cancer Requiring Cystectomy Postoperative Infections Antibiotic Prophylaxis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tailoring the preventive antibiotic given before bladder removal surgery (cystectomy) based on the patient's own bacteria profile reduces the risk of post-surgical infections, compared to the standard approach of giving the same antibiotic to all patients. **You may be eligible if...** - You are 18 or older - You are scheduled to have your bladder removed (cystectomy) for cancer or another condition - Your surgery will include creating an ileal conduit (a piece of bowel used to route urine out of the body) - You are able to understand and sign consent **You may NOT be eligible if...** - You have had a severe allergic reaction to antibiotics in the past - You are on long-term antibiotic therapy that will continue after surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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