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Prophylactic Antibiotics for Bladder Cancer

Phase < 1
Recruiting
Led By Hamed Ahmadi
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion
Must not have
Currently receiving antimicrobials for active infection
Poor renal function with GFR < 30 ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 and 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether it is necessary to give patients with bladder cancer antibiotics before surgery. They want to see if not giving antibiotics is just as effective in preventing infections after surgery as giving a specific antibiotic

Who is the study for?
This trial is for individuals with muscle invasive bladder cancer who are undergoing radical cystectomy and urinary diversion. Specific eligibility details aren't provided, but typically participants must meet certain health criteria to join.
What is being tested?
The study compares the effect of not using prophylactic antibiotics to taking a specific antibiotic (nitrofurantoin) after surgery, by looking at urinary tract infection rates within 90 days post-operation.
What are the potential side effects?
While specific side effects are not listed for this trial, nitrofurantoin may commonly cause stomach upset or diarrhea and rarely can lead to lung or liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have bladder cancer and will have surgery to remove my bladder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication for an infection.
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My kidney function is low, with a GFR under 30 ml/min.
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I am allergic to nitrofurantoin and cannot take any alternative antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 and 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in risk
test for non-inferiority

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment groupExperimental Treatment1 Intervention
Prophylactic antibiotics postoperatively.
Group II: Control groupActive Control1 Intervention
No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,838 Total Patients Enrolled
Hamed AhmadiPrincipal InvestigatorUniversity of Minnesota
~80 spots leftby Oct 2026
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