Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
Recruiting now · Phase 4
Conditions studied: Cystectomy, Bladder Cancer Requiring Cystectomy, Postoperative Infections, Antibiotic Prophylaxis, Ileal Conduit
In brief
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.
Key facts
- Study ID
- NCT06709196
- Run by
- Rigshospitalet, Denmark
- People needed
- 248
- Starts
- 2025-01-07
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Previous severe allergic reaction to antimicrobial treatment
- Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy
Where it is running
- Department of Urology, Rigshospitalet — Copenhagen, Denmark (enrolling)
- Department of Urology, Aalborg University Hospital — Aalborg, Denmark
- Department of Urology, Aarhus University Hospital — Aarhus, Denmark
- Department of Urology, Herlev and Gentofte Hospital — Herlev, Denmark
- Department of Urology, Odense University Hospital — Odense, Denmark
Full record on ClinicalTrials.gov
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