NCT06190197EARLY_PHASE1Recruiting

Prophylactic Antibiotics in Cystectomy With Diversion

University of Minnesota

Start Date

5/13/2024

Completion Date

10/15/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Prophylactic antibiotics postoperatively.

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Conditions

Muscle-Invasive Bladder CarcinomaRadical CystectomyIleal ConduitNeobladder Diversion

Locations

University of Minnesota

Minneapolis, Minnesota 55414

United States