Single-center, Before-and-after Study Evaluating the Impact of BacT/Alert® VIRTUO®, BioFire® Blood Culture Identification 2-BCID2 and REVEAL® (bioMérieux) on the Optimization of Antibiotic Therapy for Gram-negative Bacteremia in the ICU Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients receiving optimized antibiotic therapy (adequate and narrowest spectrum antibiotic therapy) in patients with Gram-negative bacteremia 24 hours after blood culture samples
研究概览
简要总结
Bacteremia is a frequent infection in intensive care units. It is associated with a high mortality rate and the rapid implementation of appropriate antibiotic therapy is strongly correlated to patient clinical outcomes.
Innovative technologies have emerged to shorten the turnaround time of blood culture samples by obtaining susceptibility testing of the incriminated pathogen at an early stage, and therefore to rapidly adjust the antibiotic therapy of patients with Gram-negative Bacilli bacteremia.
The study investigators hypothesize that the implementation of the innovative BacT/Alert® VIRTUO®, BioFire® BCID2 and REVEAL® solutions for the analysis of blood culture samples will increase the proportion of patients with Gram-negative Bacilli bacteremia who receive appropriate and optimized antibiotic therapy 24 hours after blood culture collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 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
- •The patient must be a member or beneficiary of a health insurance plan
- •Patient admitted to the ICU with at least one positive blood culture for Gram-negative bacteremia
- •For the 'after' section of the study only:
- •Patient must have given their free and informed consent or included by emergency procedure
- •Patient signed the consent form or included by emergency procedure
排除标准
- •The subject is participating in this study, or is in a period of exclusion determined by a previous study
- •Consent refusal
- •Patient with a polymicrobial blood culture
- •Patient with a second episode of bacteremia
- •Moribund patient
研究组 & 干预措施
After innovative diagnostic technologies
干预措施: Innovative diagnostic technologies (Diagnostic Test)
After innovative diagnostic technologies
干预措施: Reference diagnostic technique (Diagnostic Test)
结局指标
主要结局
Proportion of patients receiving optimized antibiotic therapy (adequate and narrowest spectrum antibiotic therapy) in patients with Gram-negative bacteremia 24 hours after blood culture samples
时间窗: 24 hours
Yes/no: receiving optimized antibiotic therapy (effective and narrowest spectrum for the identified pathogen(s)) 24 hours after blood culture collection, before and after implementation of the new diagnostic solutions
次要结局
- Time to adapt antibiotic therapy (optimized) based on susceptibility testing between the two periods of the study (before and after the implementation of innovative diagnostic technologies) following the collection of blood cultures(28 Days)
- Concordance of the REVEAL® rapid antibiotic susceptibility testing technology with reference methods(28 Days)
- Patient survival(28 Days)
- Length of stay in intensive care unit(28 Days)
- Prevalence rate of multiresistant bacteria between the "before" and "after" periods(28 Days)
- Prevalence rate of bacteria which are highly resistant to emerging antibiotics between the "before" and "after" periods(28 Days)
- cost of the device for the healthcare facility(28 Days)
- Compare the amount per patient from the health insurance point of view.(28 Days)