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Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
Sponsor: Rigshospitalet, Denmark
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.
Official title: REINFORCE - Reducing Infection-related Readmissions Following Cystectomy. a Multicentre Randomised Clinical Trial Testing Superiority of Individualised Targeted Antibiotic Prophylaxis Over Empiric Prophylaxis At Ureteral Stent Removal to Reduce Infection-related Readmissions Following Cystectomy.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
248
Start Date
2025-01-07
Completion Date
2027-01
Last Updated
2025-01-09
Healthy Volunteers
No
Conditions
Interventions
Pivmecillinam
Orally administered pivmecillinam 400mg
Pivmecillinam
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Amoxicillin clavulanic acid
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Amoxicillin
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Cefuroxime
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Ciprofloxacin
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Linezolid
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Nitrofurantoin
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Trimethoprim
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Sulfamethoxazole trimethoprim
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Fluconazole
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Locations (5)
Department of Urology, Aalborg University Hospital
Aalborg, Denmark
Department of Urology, Aarhus University Hospital
Aarhus, Denmark
Department of Urology, Rigshospitalet
Copenhagen, Denmark
Department of Urology, Herlev and Gentofte Hospital
Herlev, Denmark
Department of Urology, Odense University Hospital
Odense, Denmark