This phase IV trial evaluates if not taking oral prophylactic antibiotics is as effective as taking oral prophylactic antibiotics in preventing urinary tract infections (UTI) after radical cystectomy with urinary diversion (postoperative) in patients with muscle invasive bladder cancer (MIBC). Standard treatment for MIBC is surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy) along with making a new way for urine to leave the body (urinary diversion). UTI is one of the most common complications and the leading reason for readmission following radical cystectomy. Antibiotics are commonly used to prevent UTI in the postoperative setting (prophylactic). Long-term antibiotic use is associated with side effects, additional costs for patients, and destruction of protective organisms. Antibiotic use could potentially destroy protective organisms and cause an increase in UTI rates due to opportunistic organisms. Not taking oral prophylactic antibiotics may be as effective as taking oral prophylactic antibiotics in preventing postoperative UTI in patients with MIBC.
Additional locations may be listed on ClinicalTrials.gov for NCT06190197.
Locations matching your search criteria
United States
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer CenterStatus: Active
Contact: Hamed Ahmadi
Phone: 612-625-2667
PRIMARY OBJECTIVE:
I. 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.
SECONDARY OBJECTIVES:
I. Compare the difference in risk of UTI within the first 30 days postoperative between treatment and no treatment groups.
II. Compare the difference in risk of UTI-related readmission in the first 30 and 90 days, postoperative, between treatment and no treatment groups.
III. Compare the distribution of pathogens (e.g., Candida, Enterobacter, Escherichia coli [E. coli]) resulting in UTI between treatment and no treatment groups.
IV. Compare antibiotic susceptibility of pathogens to evaluate for resistance patterns to nitrofurantoin between treatment and no treatment groups.
V. Compare risk of antibiotic related side effects between treatment and no treatment groups.
VI. Compare the infectious complication rate between the groups.
VII. Compare the overall complication rate between the groups.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo planned radical cystectomy with urinary diversion and receive standard care. Patients do not receive prophylactic antibiotics post-operatively.
ARM 2: Patients undergo planned radical cystectomy with urinary diversion and receive standard care. Starting 24 hours after surgery, patients receive prophylactic antibiotics with either nitrofurantoin, cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin orally (PO) daily for either 10 days or 21 days post operatively in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at days 10, 21, 30, 45, 60, and 90 days following surgery per standard of care.
Trial PhasePhase IV
Trial Typesupportive care
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorHamed Ahmadi
