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

  • End date
    Sep 2, 2025
  • participants needed
  • sponsor
    Roswell Park Cancer Institute
Updated on 10 May 2022
radical cystectomy
antibiotic therapy
invasive bladder cancer
bladder tumor


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.



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.


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.

Condition Bladder Carcinoma, Refractory Bladder Carcinoma, Urinary Tract Infection
Treatment levofloxacin, Trimethoprim-Sulfamethoxazole, Clindamycin, ertapenem, Nitrofurantoin, Diary
Clinical Study IdentifierNCT04502095
SponsorRoswell Park Cancer Institute
Last Modified on10 May 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note