Prophylactic Antibiotics in Cystectomy With Diversion

NCT06190197 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: URO-2023-32133
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• test for non-inferiority

  Test for non-inferiority of no 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.

  90 days

• Difference in risk

  Difference in risk of UTI within the first 30 days postoperative between treatment and no treatment groups. 2-sample, 2-sided, t-test for a difference in proportions. Statistical hypothesis: H0: R1 - R2 = 0, Hα: R1 - R2 ≠ 0, where R1 is the risk (proportion) of UTI infection within the first 30 days, post operation, among those in the treatment group, and R2 among placebo.

  30 and 90 days

Study Arms (2)

Control group

NO INTERVENTION

No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection

Treatment group

EXPERIMENTAL

Prophylactic antibiotics postoperatively.

Drug: Prophylactic antibiotics postoperatively.

Interventions

Prophylactic antibiotics postoperatively. DRUG

Prophylactic antibiotics postoperatively. All participants in this arm will receive nitrofurantoin 100 milligrams by mouth daily for either 10 or 21 days based on whether they had an ileal conduit or orthotopic neobladder, respectively, for the diversion. Participants will be instructed to swallow the capsule whole, preferably with food and at the same time each day. If a dose is forgotten, participants will be asked to take it when they remember and then take the next dose as usual. However, if they do not remember until the next dose, do not take extra capsules to make up the missed dose.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion.
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Study Officials

• Hamed Ahmadi

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Graziano

CONTACT

612-625-7486; grazi005@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized non-inferiority trial.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 5, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

US (1)