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
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of patients enrolled
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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)
排除标准
- •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)
研究组 & 干预措施
Antimicrobial and catheter change
干预措施: Antimicrobial (Drug)
Antimicrobial and catheter change
干预措施: Catheter change (Device)
Catheter change and NO antimicrobial
干预措施: Catheter change (Device)
Antimicrobial and NO catheter change
干预措施: Antimicrobial (Drug)
结局指标
主要结局
Number of patients enrolled
时间窗: 18 months
none enrolled
Protocol Adherence Rate
时间窗: 18 months
次要结局
- Developement of resistance(14 days)
- ICU free days at Day 30(30 days)
- Microbiologic Outcome(Day 7 and 14)