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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Previous severe allergic reaction to antimicrobial treatment

Long-term prophylactic antibiotic treatment which is expected to be continued after the cystectomy

Trial design

Treatments tested in this trial

  • Pivmecillinam
  • Pivmecillinam
  • Amoxicillin clavulanic acid
  • Amoxicillin
  • Cefuroxime
  • Ciprofloxacin
  • Linezolid
  • Nitrofurantoin
  • Trimethoprim
  • Sulfamethoxazole trimethoprim
  • Fluconazole

Treatment groups

248 Participants
are divided into 2 treatment groups

Sponsors and collaborators