Donate
Back to Clinical Trials
Back to Clinical Trials

Brief Title: Prophylactic Antibiotics in Cystectomy With Diversion

Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion

INTRODUCTION

  • Org Study ID: URO-2023-32133
  • Secondary ID: N/A
  • NCT ID: NCT06190197
  • Sponsor: University of Minnesota

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 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.

  • Overall Status
    Recruiting
  • Start Date
    May 13, 2024
  • Phase
    Early Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Muscle-Invasive Bladder Carcinoma
  • Radical Cystectomy
  • Ileal Conduit
  • Neobladder Diversion

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Hamed Ahmadi

Role: Principal Investigator

Affiliation: University of Minnesota

Overall Contact

Name: Maressa Twedt

Phone: 612-626-6661

Email: twedt050@umn.edu

LOCATION

Facility Status Contact
Facility: University of Minnesota
Minneapolis, Minnesota 55414
United States 		Status: Recruiting Contact: Contact
Maressa Twedt
612-626-6661
twedt050@umn.ed

Read Our Stories