Prophylactic Antibiotics in Cystectomy With Diversion

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06190197
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 13, 2024
Status verified
Nov 2025
Primary completion
Oct 15, 2027
Completion
Oct 15, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control group
    No prophylactic antibiotics post operatively. Participants will receive antibiotics only if needed post-operatively such as for infection
  • Experimental: Treatment group
    Prophylactic antibiotics postoperatively.

Primary Outcome Measure

test for non-inferiority [ Time Frame: 90 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Judith Graziano
[email protected]
612-625-7486

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By research site
University of Minnesota· Minneapolis, MN

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