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临床试验/NCT03583762
NCT03583762Unknown不适用

Comparison of Time to Appropriate Antibiotic Between Using Microarray Assay and Mass Spectrometry Technique for Identification of Positive Blood Cultures

Chiang Mai University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
To compare the time to appropriate antibiotic therapy in patients with positive blood cultures between using Microarray assays versus Mass Spectrometry technique for Identification of Positive Blood Cultures

研究概览

简要总结

This is an experimental study of participants who had positive blood culture to compare time to appropriate antibiotic between using Microarray Assay and Mass Spectrometry to bacterial Identification.

详细描述

Between June to Dec 2018, 200 participants those met the eligibility criteria were enrolled in this study that is a quasi experimental study. All participants were empirical antibiotic therapy by infectious physician. 100 patients in Pre-intervention group had bacterial identification by Mass spectrometry technique from bacterial colony and 100 patients in Post-intervention group had bacterial identification by Microarray assay from blood culture. Antibiotic adjustment were considered after bacterial identification and result of antibiotic susceptibility testing. Then all participants were re-evaluated outcome after treatment. Finally, the results were ready to analysis in January 2019.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

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

  • •Age ≥ 18 year old with positive hemoculture between June 2018 and Dec 2018
  • •Internal medicine wards patients at Maharaj Nakorn Chiang Mai Hospital
  • •Ability to provide informed consent

排除标准

  • •Suspected contaminated positive blood culture
  • •Bacteremia cause by more than two species of bacteria, as suspected from the gram staining examinations
  • •Terminally ill patients

研究组 & 干预措施

Pre-intervention group

Experimental

100 participants received empiric antibiotic by ID physician, bacterial identification by Mass spectrometry technique

干预措施: Mass spectrometry (Diagnostic Test)

Post-intervention group

Experimental

100 participants received empiric antibiotic therapy by ID physician, bacterial identification by Microarray assay from blood culture and confirm with Mass spectrometry technique

干预措施: Microarray assay (Diagnostic Test)

结局指标

主要结局

To compare the time to appropriate antibiotic therapy in patients with positive blood cultures between using Microarray assays versus Mass Spectrometry technique for Identification of Positive Blood Cultures

时间窗: 4 days from positive hemoculture

Comparison of time that participants received appropriate antibiotic therapy between 2 study period (Mass spectrometry technique and Microarray assay group)

次要结局

  • Cost of antibiotic therapy(14 days)
  • Mortality rate at 2 weeks(14 days from positive hemoculture)
  • Length of hospital stays(30 days)
  • Percentage of De-escalation or escalation antibiotic(14 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

研究点 (1)

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