Testing antibiotics for preventing infections after bladder surgery
Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion
EARLY_PHASE1 · University of Minnesota · NCT06190197
This study tests whether giving antibiotics before bladder surgery can help prevent infections in patients with muscle-invasive bladder cancer compared to not using antibiotics at all.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06190197 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of prophylactic antibiotics in preventing postoperative urinary tract infections in patients undergoing radical cystectomy for muscle-invasive bladder cancer. It employs a randomized two-arm design to compare the rates of infections in patients receiving nitrofurantoin versus those receiving no antibiotics. The study aims to determine if avoiding antibiotics is non-inferior in terms of infection rates within 90 days post-surgery. Participants must be 18 years or older and meet specific eligibility criteria related to their health status and cancer diagnosis.
Who should consider this trial
Good fit: Ideal candidates are adults with muscle-invasive bladder cancer scheduled for radical cystectomy with urinary diversion.
Not a fit: Patients currently on antimicrobials for active infections or with poor renal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce unnecessary antibiotic use and its associated risks while maintaining patient safety.
How similar studies have performed: Other studies have explored antibiotic prophylaxis in surgical settings, but this specific comparison of non-use versus nitrofurantoin is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Prior pelvic radiation
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Hamed Ahmadi — University of Minnesota
- Study coordinator: Judith Graziano
- Email: grazi005@umn.edu
- Phone: 612-625-7486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Muscle-Invasive Bladder Carcinoma, Radical Cystectomy, Ileal Conduit, Neobladder Diversion