Status:
COMPLETED
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Bladder Carcinoma
Refractory Bladder Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04502095
Start Date
September 2 2020
End Date
March 13 2025
Last Update
August 3 2025
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263