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Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

RecruitingPhase 4Ages 18 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT06709196 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Previous severe allergic reaction to antimicrobial treatment * Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy
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What it tests

  • Pivmecillinam
  • Pivmecillinam
  • Amoxicillin clavulanic acid
  • Amoxicillin
  • Cefuroxime
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Where

5 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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