Prophylactic Antibiotics in Cystectomy With Diversion

Muscle-Invasive Bladder Carcinoma Clinical Trial

Official title:

Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190197
• Other study ID #: URO-2023-32133
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 13, 2024
• Est. completion date: October 15, 2026

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: Maressa Twedt
• Phone: 612-626-6661
• Email: twedt050[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 15, 2026
• Est. primary completion date: October 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Ileal Conduit
• Muscle-Invasive Bladder Carcinoma
• Radical Cystectomy
• Urinary Bladder Neoplasms

Intervention

Drug:
• Prophylactic antibiotics postoperatively.
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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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, Ha: 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