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临床试验/NCT03114358
NCT03114358已完成不适用

A Cluster Randomized Controlled Trial Comparing Early and Late Carbapenems De-escalation in the Medicine Units, Maharaj Nakorn Chiang Mai Hospital

Chiang Mai University0 个研究点目标入组 104 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
104
主要终点
The rate of de-escalation within the first 24 hour

研究概览

简要总结

Early de-escalation of carbapenems can reduce unnecessary use of carbaepenems compared with late de-escalation without compromised clinical outcomes

详细描述

A cluster randomized control trial was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital.

Patients were randomly assigned into 2 groups. The standard group followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team. The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).

Clinical outcomes included rate of de-escalation within the first 24 hour, the mortality rate, and other clinical outcomes.

研究设计

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

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All adult patients aged ≥ 15 years old
  • •received carbapenems (meropenem and imipenem/cilastatin) empirically within 24-72 hours for the first time during admission
  • •able to sign informed consent

排除标准

  • •They were in the intensive care units, or had neutropenia (absolute neutrophil count < 1,000 cell/mm3)

研究组 & 干预措施

Early carbapenems de-escalation

Experimental

De-escalation carbapenems within 24 hours or no later than 72 hours of prescription by Infectious disease specialist (early de-escalation).

干预措施: Early Carbapenem de-escalation (Other)

Late carbapenems de-escalation

No Intervention

De-escalation followed the hospital policy in which carbapenems were evaluated by ID specialist at 72 hours of admission (late de-escalation). De-escalation may occurred earlier depends upon the decision of the primary care team

结局指标

主要结局

The rate of de-escalation within the first 24 hour

时间窗: 24 hours

Compare the rate of de-escalation within the first 24 hour between arm 1 and arm 2

次要结局

  • Mortality rate(90 days)
  • Readmission within 30 days,(30 days)
  • Costs of carbapenems(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Romanee Chaiwarith

Associate professor

Chiang Mai University

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