NCT04502095

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Carcinoma
• Refractory Bladder Carcinoma
• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Clindamycin	Given PO
OTHER	Diary	Complete drug diary
DRUG	Ertapenem	Given PO
DRUG	Levofloxacin	Given PO
DRUG	Nitrofurantoin	Given PO
DRUG	Trimethoprim-Sulfamethoxazole	Given PO

Timeline

• Start date: 2020-09-02
• Primary completion: 2025-03-13
• Completion: 2025-03-13
• First posted: 2020-08-06
• Last updated: 2025-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study