Clinical trial NCT04502095: Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
Official title: Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Bladder Carcinoma
Refractory Bladder Carcinoma
Urinary Tract Infection
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Intravenously (IV), levofloxacin, or clindamycin IV at induction 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 IV, levofloxacin IV or clindamycin IV at induction per standard of care.

After surgery, patients are followed up to 120 days.

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

Primary outcomes:
measure: 90-day urinary tract infection (UTI) status
timeFrame: At 90 days after surgery
Secondary outcomes:
measure: Identify pre-operative factors associated with the development of UTI
timeFrame: Up to 120 days after surgery
measure: Development of Clostridium difficile (C Diff)
timeFrame: up to 120 days after surgery
measure: Infections occurring during antibiotic use
timeFrame: Up to 120 days after surgery
measure: Identify post operative factors associated with the development of UTI
timeFrame: Up to 120 days after surgery
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Khurshid A Guru
role: PRINCIPAL_INVESTIGATOR
References: