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BRIEF TITLE: Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy


  • Org Study ID: I 573720
  • Secondary ID: NCI-2020-04928,I 573720
  • NCT ID: NCT04502095
  • NCT Alias:
  • Sponsor: Roswell Park Cancer Institute - Other
  • Source: 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.

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

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: At 90 days after surgery

Condition:

  • Bladder Carcinoma
  • Refractory Bladder Carcinoma
  • Urinary Tract Infection

Eligibility

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
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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

Location

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