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

  • STATUS
    Recruiting
  • End date
    Aug 15, 2025
  • participants needed
    100
  • sponsor
    Roswell Park Cancer Institute
Updated on 24 January 2021
radical cystectomy
antibiotic therapy
antibiotics
ertapenem
cancer
trimethoprim
sulfamethoxazole
trimethoprim-sulfamethoxazole
invasive bladder cancer
bladder tumor
nitrofurantoin

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.

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 orally (PO), levofloxacin PO, or clindamycin PO induction therapy 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 PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

After surgery, patients are followed up to 120 days.

Details
Condition bladder cancer, Urinary tract infection, Urothelial Cancer, Recurrent Urinary Tract Infection, Recurrent Urinary Tract Infections, Urinary Tract Infections, Bladder Carcinoma, Refractory Bladder Carcinoma, carcinoma of the bladder, urinary tract infection (uti), urinary infection, recurrent utis
Treatment levofloxacin, Trimethoprim-Sulfamethoxazole, Clindamycin, ertapenem, Nitrofurantoin, Diary
Clinical Study IdentifierNCT04502095
SponsorRoswell Park Cancer Institute
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Bladder Carcinoma or Urinary tract infection or Refractory Bladder Carcinoma or bladder cancer or Urinary Tract Infections or Urothelial Cancer?
Do you have any of these conditions: Urinary Tract Infections or Urothelial Cancer or Recurrent Urinary Tract Infections or Recurrent Urinary Tract Infection or carcinoma of the bladder o...?
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
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