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Brief Title: 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

INTRODUCTION

  • Org Study ID: I 573720
  • Secondary ID: NCI-2020-04928, I 573720
  • NTC ID: NCT04502095
  • Sponsor: Roswell Park Cancer Institute

BRIEF 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 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.

  • Overall Status
    Recruiting
  • Start Date
    August 4, 2020
  • Phase
    Phase 4
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: 90-day urinary tract infection (UTI) status

Primary Outcome 1 - Timeframe: At 90 days after surgery

CONDITION

  • Bladder Carcinoma
  • Refractory Bladder Carcinoma
  • Urinary Tract Infection

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Khurshid A Guru

Role: Principal Investigator

Affiliation: Roswell Park Cancer Institute

Overall Contact

Name: Khurshid A Guru

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact: Contact
Khurshid A. Guru
716-845-4107
Khurshid.Guru@roswellpark.org