RECRUITINGPhase 4INTERVENTIONAL

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.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age at surgery ≥ 18 years - Ability to understand and sign an willing to sign a consent form - Malignant or benign indication for undergoing cystectomy - Planned ileal conduit as urinary diversion Who Should NOT Join This Trial: - Previous severe allergic reaction to antimicrobial treatment - Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age at surgery ≥ 18 years * Ability to understand and sign an informed consent * Malignant or benign indication for undergoing cystectomy * Planned ileal conduit as urinary diversion Exclusion Criteria: * Previous severe allergic reaction to antimicrobial treatment * Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy

Treatments Being Tested

DRUG