Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
- Conditions
- Bladder CarcinomaUrinary Tract InfectionRefractory Bladder Carcinoma
- Interventions
- Other: DiaryDrug: Trimethoprim-Sulfamethoxazole
- Registration Number
- NCT04502095
- Lead 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 89
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group II (standard of care) Clindamycin Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. Group II (standard of care) Ertapenem Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) Diary 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. Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) 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. Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) Trimethoprim-Sulfamethoxazole 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. Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) Clindamycin 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. Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) Ertapenem 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. Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) Levofloxacin 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. Group II (standard of care) Levofloxacin Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
- Primary Outcome Measures
Name Time Method 90-day urinary tract infection (UTI) status At 90 days after surgery Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.
- Secondary Outcome Measures
Name Time Method Identify post operative factors associated with the development of UTI Up to 120 days after surgery stratified logistic regression models (stratified by antibiotic use)
Identify pre-operative factors associated with the development of UTI Up to 120 days after surgery stratified logistic regression models (stratified by antibiotic use)
Development of Clostridium difficile (C Diff) up to 120 days after surgery Will be evaluated in patients who received prophylactic antibiotics.
Infections occurring during antibiotic use Up to 120 days after surgery To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States