Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- 90-day urinary tract infection (UTI) status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Clindamycin (Drug)
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.
干预措施: Diary (Other)
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.
干预措施: Ertapenem (Drug)
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.
干预措施: Levofloxacin (Drug)
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.
干预措施: Nitrofurantoin (Drug)
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.
干预措施: Trimethoprim-Sulfamethoxazole (Drug)
Group II (standard of care)
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
干预措施: Clindamycin (Drug)
Group II (standard of care)
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
干预措施: Ertapenem (Drug)
Group II (standard of care)
Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
干预措施: Levofloxacin (Drug)
结局指标
主要结局
90-day urinary tract infection (UTI) status
时间窗: At 90 days after surgery
Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.
次要结局
- 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)