Actively Recruiting
Led by Rigshospitalet, Denmark · Updated on 2025-01-09
248
Participants Needed
5
Research Sites
N/A
Total Duration
Researchers are evaluating whether postoperative antibiotics targeted to bacteria found in urine can reduce infections after bladder removal surgery (cystectomy) compared to a standard antibiotic approach. This trial focuses on patients undergoing cystectomy, a surgery with a high risk of infection and readmission within 90 days. The study aims to improve recovery by testing a more personalized antibiotic strategy against the current standard treatment. Participants will be randomly assigned to one of two groups after surgery: one group will receive a standard antibiotic called pivmecillinam taken three times on the day of ureteral stent removal, while the other group will receive a single-day targeted antibiotic based on bacteria detected in a postoperative urine sample. If no bacteria are found, no antibiotics will be given. All other care before, during, and after surgery will follow usual hospital guidelines. During the 90-day follow-up, participants will provide urine samples and complete quality of life questionnaires before and after surgery. Researchers will collect data on infection-related hospital readmissions, complications, and antibiotic use from medical records. The main goal is to see if the targeted antibiotic reduces infections leading to readmission within 90 days. The study includes detailed monitoring and plans for early analysis to ensure participant safety and study effectiveness.
CONDITIONS
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the urological outpatient clinic
Duration - Day of ureteral stent removal
Participants undergo cystectomy surgery and receive antibiotic prophylaxis on the day of ureteral stent removal. They are randomized to receive either a single-day targeted antibiotic based on urine culture results or three doses of standard empiric antibiotic pivmecillinam.
1 visit on the day of ureteral stent removal (in-person)
Duration - 90 days postoperatively
Participants are followed for 90 days after surgery to monitor infection-related readmissions, postoperative complications, readmissions, and quality of life. Data is collected from medical records and questionnaires.
Questionnaires completed electronically at baseline and 90 days; clinical data collected from medical records
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
M
Maja Vejlgaard
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Maja Vejlgaard, Hein Vincent Stroomberg, Mie Skjøttgaard Ynddal...
https://pubmed.ncbi.nlm.nih.gov/40722189