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临床试验/NCT06218277
NCT06218277招募中不适用

Rapid Antimicrobial Susceptibility Testing With MIC Directly From Positive Blood Cultures With ASTar

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Time tot first effective antibiotic therapy

研究概览

简要总结

The investigators want to investigate the clinical impact of early antimicrobial susceptibility results for gram negative bacilli isolated from blood cultures on antimicrobial choices and early switches of antimicrobial therapy.

详细描述

Sepsis and septic shock are defined as a (life-threatening) organ dysfunction caused by an (uncontrolled) host response to an infection. Sepsis remains a leading cause of morbidity and mortality worldwide. In addition, sepsis is also associated with prolonged hospitalization and additional healthcare costs.

Sepsis and septic shock can be caused by a bloodstream infection. If bloodstream infection is suspected, blood cultures are collected.

In recent years, various devices and methods have been developed to make an antibiogram possible after a few hours, instead of the next day. The Q-linea AStar system will be used for this purpose in the medical microbiology laboratory. In contrast to the classic method, blood from the blood culture is not grafted onto a growth medium, but this blood is placed in a specific cartridge on the device, after which automatic sample processing takes place, which after six hours leads to a definitive susceptibility result for a large number of gram-negative bacilli and causes of bloodstream infections. Moreover, the reported antibiogram is not based on disk diffusion but on 'broth' microdilution (ISO 2776-1) where the sensitivity to a specific antibiotic is determined on the basis of a dilution series. This method allows sensitivity to be reported not only qualitatively (sensitive or resistant), but also allows reporting of the minimum inhibitory concentration (MIC value). This is the lowest concentration of an antibiotic at which the growth of the bacteria is inhibited and this fact allows the dose administered to be optimized if necessary.

The aim of this study is therefore, if this new method can be implemented, to retrospectively determine whether making the antibiogram more quickly available in the epidemiological setting of Ghent University Hospital offers added value: does the early available information lead to necessary and beneficial antibiotherapy changes or does the traditional diagnosis with reporting one day later prove to be equivalent? If the new working method were to lead to a clinically significant improvement in the established policy, this could necessitate an organizational adjustment in the operation of the laboratory.

To gain insight into this, clinical data will be collected during the study period necessary to evaluate the extent to which the faster results have had an impact on the antibiotherapy. There is therefore no need for additional sample collection from the patient. All collected data result from the standard hemoculture taken due to fever and/or frissons and concern clinical data that is routinely collected to formulate antibiotic recommendations for patients with positive hemocultures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with blood culture positive with gram negative bacilli

排除标准

  • Mixed blood culture positivity on Gram stain
  • Positive blood culture with gram negative bacilli in the previous 7 days
  • Life expectancy of < 48 hours

结局指标

主要结局

Time tot first effective antibiotic therapy

时间窗: 24 hours

Time tot first effective antibiotic therapy

次要结局

  • Number of different antibiotic classes used in treatment(14 days)
  • Time of empiric treatment(72 hours)
  • Time to optimal antibiotic therapy(72 hours)
  • Time to stop antibiotic therapy(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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