Actively Recruiting
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
Led by Rigshospitalet, Denmark · Updated on 2025-01-09
248
Participants Needed
5
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at surgery 218 years
- Ability to understand and sign an informed consent
- Malignant or benign reason for cystectomy
- Planned ileal conduit urinary diversion
You will not qualify if you...
- Previous severe allergic reaction to antimicrobial treatment
- Long-term prophylactic antibiotic treatment expected to continue after cystectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Department of Urology, Aalborg University Hospital
Aalborg, Denmark, 9100
Not Yet Recruiting
2
Department of Urology, Aarhus University Hospital
Aarhus, Denmark, 8200
Not Yet Recruiting
3
Department of Urology, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Department of Urology, Herlev and Gentofte Hospital
Herlev, Denmark, 2730
Not Yet Recruiting
5
Department of Urology, Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
Research Team
M
Maja Vejlgaard
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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