drugset / Trial / NCT06709196

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

NCT06709196

Phase 4 Recruiting 248 enrolled Rigshospitalet, Denmark
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2025-01-07
Primary completion
2027-01
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified Oral
Subject Cefuroxime Small molecule Oral
Subject Ciprofloxacin Small molecule Oral
Subject Fluconazole Small molecule Oral
Subject Linezolid Other / unclassified Oral
Subject Nitrofurantoin Unknown Oral
Subject Pivmecillinam Small molecule 400 mg Oral
Subject Trimethoprim Small molecule Oral
Subject trimethoprim-sulfamethoxazole Unknown Oral