Status:
RECRUITING
Prophylactic Antibiotics in Cystectomy With Diversion
Lead Sponsor:
University of Minnesota
Conditions:
Muscle-Invasive Bladder Carcinoma
Radical Cystectomy
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 compar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06190197
Start Date
May 13 2024
End Date
October 15 2027
Last Update
November 17 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414