This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.
PRIMARY OBJECTIVE: I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy. SECONDARY OBJECTIVE: I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (ANTIBIOTIC): Patients receive ertapenem Intravenously (IV), levofloxacin, or clindamycin IV at induction per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic. GROUP II (CONTROL): Patients receive ertapenem IV, levofloxacin IV or clindamycin IV at induction per standard of care. After surgery, patients are followed up to 120 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Given PO
Complete drug diary
Given PO
Given PO
Given PO
Given PO
Roswell Park Cancer Institute
Buffalo, New York, United States
90-day urinary tract infection (UTI) status
Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.
Time frame: At 90 days after surgery
Identify pre-operative factors associated with the development of UTI
stratified logistic regression models (stratified by antibiotic use)
Time frame: Up to 120 days after surgery
Development of Clostridium difficile (C Diff)
Will be evaluated in patients who received prophylactic antibiotics.
Time frame: up to 120 days after surgery
Infections occurring during antibiotic use
To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.
Time frame: Up to 120 days after surgery
Identify post operative factors associated with the development of UTI
stratified logistic regression models (stratified by antibiotic use)
Time frame: Up to 120 days after surgery
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