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临床试验/NCT01587937
NCT01587937已完成不适用

Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 19,220 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19,220
试验地点
2
主要终点
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)

研究概览

简要总结

Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has published guidelines stating that all hospitals should develop an institutional program to enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic stewardship audit-and-feedback intervention for all patients reaching their third or tenth day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The investigators hypothesize that this intervention will result in similar benefits outside of the intensive care unit, and so expanded the intervention to non-ICU medical and surgical wards. To increase the rigor of our program evaluation, the roll-out was conducted in a stepped-wedge randomized controlled design.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • admitted to one of these services: general internal medicine, cardiology, nephrology, orthopedic surgery, neurosurgery, general surgery or trauma surgery
  • receiving 3rd or 10th day of treatment with one of the following antibiotics:
  • ceftriaxone, ceftazidime, piperacillin-tazobactam, ciprofloxacin, levofloxacin, meropenem, ertapenem, vancomycin

排除标准

  • patient being followed by the infectious diseases consult service

结局指标

主要结局

Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)

时间窗: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)

* Targeted broadspectrum antibiotics include third generation cephalosporins (ceftriaxone, ceftazidime), beta-lactam beta-lactamase inhibitors (piperacillin-tazobactam), fluoroquinolones (ciprofloxacin, levofloxacin), carbapenems (ertapenem and meropenem), and glycopeptides (vancomycin) * DOTs are defined as the number of unique antibiotic agents prescribed each day (regardless of dose)

次要结局

  • Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))
  • Antibiotic susceptibility of gram negative bacterial isolates(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))
  • Hospital-acquired Clostridium difficile infection.(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))
  • Costs of antibiotic therapy ($) per patient day(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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