Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections. (CAUTION)
A Pilot Concealed Randomized Double-blinded Placebo-controlled Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill
Urinary tract infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alter outcomes. Our previous studies have documented wide practice variations exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore, the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics, a practice that can increase the development of resistant bacteria.
The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change and/or systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone, urine catheter change alone, and both catheter change and antibiotics. Their clinical outcomes will be assessed.
Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial. Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.
研究概览
研究类型
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Ontario
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Toronto、Ontario、加拿大、M5B1W8
- St. Michael's Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult ICU patient (≥ 18 years old)
- Admitted to the ICU for ≥ 96 hours
- Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
- Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
- Have received antimicrobial therapy that would cover the isolated organism(s) in the index urine culture for < 24 hours (i.e. therapy that does NOT cover the isolated organism(s) in the index urine culture of any duration or antimicrobial that covers the index urine organism for < 24 hours are permitted)
Exclusion Criteria:
- Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
- Anuria (< 50 mL/day)
- Imminent death within 48 hours or decision to withdraw supportive care by clinical team
- Neutropenia (< 500/mm3)
- Patient has an alternative infection and requires an antimicrobial that has a spectrum of activity which include all the organism(s) isolated from the index urine culture
- Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:No catheter change no antimicrobial
Urinary catheter will not be changed and no antimicrobials will be prescribed
|
|
有源比较器:Antimicrobial and catheter change
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Appropriate antimicrobial based on urine culture results
Change urine catheter
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有源比较器:Catheter change and NO antimicrobial
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Change urine catheter
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有源比较器:Antimicrobial and NO catheter change
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Appropriate antimicrobial based on urine culture results
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of patients enrolled
大体时间:18 months
|
none enrolled
|
18 months
|
Protocol Adherence Rate
大体时间:18 months
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18 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
ICU free days at Day 30
大体时间:30 days
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30 days
|
Microbiologic Outcome
大体时间:Day 7 and 14
|
Day 7 and 14
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Developement of resistance
大体时间:14 days
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14 days
|
合作者和调查者
合作者
调查人员
- 首席研究员:Jan Friedrich, DPhil, MD, MSc、Unity Health Toronto
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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