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Recruiting Phase 4 NCT06709196

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

Trial Parameters

Condition Cystectomy
Sponsor Rigshospitalet, Denmark
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 248
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-07
Completion 2027-01
Interventions
PivmecillinamPivmecillinamAmoxicillin clavulanic acid

Brief 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 Criteria

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

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