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

• Status: Recruiting
• Trial end date: 2025-08-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Clindamycin; Ertapenem; Levofloxacin; Nitrofurantoin; Ofloxacin; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

• Any patient that electively chooses to have a cystectomy is eligible to participate in the study. Indications for a person who may undergo a cystectomy include having a diagnosis of muscle-invasive bladder cancer (MIBC) or refractory non-muscle invasive bladder cancer (NMIBC)

• Any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent

• Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Patients with a history of myasthenia gravis

• Patients with a history of QT prolongation or taking other drugs that prolong corrected QTc (QTc) should be excluded

• Patients with renal dysfunction, creatinine clearance (mL/min) < 30

• Pregnant or nursing female participants

• Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC)

• Unwilling or unable to follow protocol requirements

• Patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge

• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug