Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis
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.
Rigshospitalet, Denmark
248 participants
Jan 7, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria2
- Previous severe allergic reaction to antimicrobial treatment
- Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy
Interventions
Orally administered pivmecillinam 400mg
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Orally administered targeted antimicrobial prophylaxis based on a urine culture.
Locations(5)
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NCT06709196