Trials / Recruiting
RecruitingNCT06190197
Prophylactic Antibiotics in Cystectomy With Diversion
Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-05-13
- Primary completion
- 2027-10-15
- Completion
- 2027-10-15
- First posted
- 2024-01-05
- Last updated
- 2025-11-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06190197. Inclusion in this directory is not an endorsement.