Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06190197

Prophylactic Antibiotics in Cystectomy With Diversion

Led by University of Minnesota · Updated on 2025-11-17

120

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prophylactic Antibiotics in Cystectomy With Diversion

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

J

Judith Graziano

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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