Antimicrobial De-escalation Strategy in Medical Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
研究概览
简要总结
The purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents.
详细描述
This is an open-label, case-control, pilot study involving medical patients with serious infections who are prescribed meropenem or piperacillin/tazobactam, at Surrey Memorial Hospital. Patients in the experimental arm (cases) will be required to provide an informed consent. A team consisting of an infectious diseases specialist, medical microbiologist and clinical pharmacists will prospectively assess antimicrobial therapy in the enrolled subjects in the prospective arm and make recommendations for antimicrobial de-escalation.
The control group will consist of subjects drawn from historic data of patients on the same medical unit(s) who will be matched based on age, sex, use of broadspectrum antibiotics (meropenem or piperacillin/tazobactam) and infectious diseases diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 years and over
- •Suspected or confirmed infection for which a Meropenem and/or Piperacillin/Tazobactam is prescribed. This will include any patient who is other concomitant antibiotic(s) such as Vancomycin
- •Subject admitted to SMH medical unit(s)
- •Pregnant patient (or patients wishing to become pregnant)
排除标准
- •Age less than 19 years
- •Granulocytopenia (< 1x109/L)
- •Allergy or intolerance to meropenem or piperacillin-tazobactam.
- •Febrile Neutropenia
- •Cystic Fibrosis
结局指标
主要结局
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
时间窗: 7 days
次要结局
- Length of stay in the hospital(14 days)
- Clinical efficacy (clinical improvement or complete resolution of infection)(7 days)
- Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation(7 days)
- Cost and consumption (usage data) of antibiotics(7 days)
- All cause mortality(14 days)