Antibiotics for Urinary Tract Infections After Bladder Surgery

Recruiting in Palo Alto (17 mi)

Overseen byKhurshid A. Guru

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Khurshid A. Guru

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for patients planning to undergo robot-assisted surgery to remove the bladder due to muscle-invasive or refractory non-muscle invasive bladder cancer. Participants must understand and consent to the study's nature. Excluded are those with myasthenia gravis, QT prolongation, severe kidney issues, pregnant/nursing women, and anyone who can't follow the protocol.

Inclusion Criteria

I choose to have a robot-assisted surgery for bladder removal and can 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

I am choosing to have a cystectomy for my bladder cancer.

Exclusion Criteria

I am a woman who had a fertility-preserving bladder surgery.

My kidney function is low, with a creatinine clearance under 30 mL/min.

I do not have a history of abnormal heart rhythms nor take medication that affects it.

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Treatment Details

Interventions

Clindamycin (Antibiotic)
Diary (Other)
Ertapenem (Antibiotic)
Levofloxacin (Antibiotic)
Nitrofurantoin (Antibiotic)
Trimethoprim-Sulfamethoxazole (Antibiotic)

Trial OverviewThe trial tests if a one-month course of antibiotics like trimethoprim-sulfamethoxazole or nitrofurantoin after robot-assisted radical cystectomy reduces urinary tract infections. It aims to improve post-surgery outcomes and manage complications better.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)Experimental Treatment6 Interventions

Patients receive ertapenem 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: Group II (standard of care)Active Control3 Interventions

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

Clindamycin is already approved in Canada, Japan for the following indications: