RECRUITING

Prophylactic Antibiotics in Cystectomy With Diversion

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion

Quick Facts

Study Start:2024-05-13
Study Completion:2026-10-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06190197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
  2. * 18 years of age or older
  1. * Currently receiving antimicrobials for active infection
  2. * Poor renal function with GFR \< 30 ml/min
  3. * Allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
  4. * Pregnancy
  5. * Unable to provide Informed consent

Contacts and Locations

Study Contact

Maressa Twedt
CONTACT
612-626-6661
twedt050@umn.edu

Principal Investigator

Hamed Ahmadi
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

  • Hamed Ahmadi, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-13
Study Completion Date2026-10-15

Study Record Updates

Study Start Date2024-05-13
Study Completion Date2026-10-15

Terms related to this study

Additional Relevant MeSH Terms

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