Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy
Overview
- Phase
- Phase 4
- Intervention
- Clindamycin
- Conditions
- Bladder Carcinoma
- Sponsor
- Roswell Park Cancer Institute
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- 90-day urinary tract infection (UTI) status
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
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
Arms & Interventions
Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
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.
Intervention: Clindamycin
Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
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.
Intervention: Diary
Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
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.
Intervention: Ertapenem
Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
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.
Intervention: Levofloxacin
Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
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.
Intervention: Nitrofurantoin
Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
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.
Intervention: Trimethoprim-Sulfamethoxazole
Group II (standard of care)
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
Intervention: Clindamycin
Group II (standard of care)
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
Intervention: Ertapenem
Group II (standard of care)
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
Intervention: Levofloxacin
Outcomes
Primary Outcomes
90-day urinary tract infection (UTI) status
Time Frame: At 90 days after surgery
Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.
Secondary Outcomes
- Identify post operative factors associated with the development of UTI(Up to 120 days after surgery)
- Identify pre-operative factors associated with the development of UTI(Up to 120 days after surgery)
- Development of Clostridium difficile (C Diff)(up to 120 days after surgery)
- Infections occurring during antibiotic use(Up to 120 days after surgery)