Prophylactic Antibiotics in Cystectomy With Diversion
Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle i
| Condition(s) | Muscle-Invasive Bladder Carcinoma, Radical Cystectomy, Ileal Conduit, Neobladder Diversion |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion. |
| Who can participate | Inclusion Criteria: * Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion. * 18 years of age or older Exclusion Criteria: * Currently receiving antimicrobials for active infection * Poor renal function with GFR \< 30 ml/min * Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin) * Pregnancy * Unable to provide Informed consent * Prior pelvic radiation |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Minnesota |
| Locations | Minneapolis, Minnesota, United States |
| Start date | 2024-05-13 |
| NCT ID | NCT06190197 |
| Official listing | https://clinicaltrials.gov/study/NCT06190197 |