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临床试验/NCT02516514
NCT02516514已完成不适用

The Only Blood Culture for Diagnosis of Bacteremia - Comparative Study of Practice

University Hospital, Caen0 个研究点目标入组 302 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
302
主要终点
Rate of pathogens identified by each strategy

研究概览

简要总结

Current recommendations for the diagnosis of bacteremia based on the embodiment February-March blood cultures separated by a minimum interval of 30 minutes. Each blood culture comprises seeding a pair of aerobic and anaerobic vials inoculated each with 5 to 10 ml of blood. The sensitivity and specificity of this technique depends essentially on the amount of blood removed since there is a direct relationship between the volume of blood inoculated into each flask and the efficiency of the technique. A preliminary study conducted at the University Hospital of Caen found that 14-30% of patients depending on the services had received only one blood culture. In addition, at least four blood cultures in 24 hours were taken for 10 to 20% of patients. The practice of a single blood culture reduces the sensitivity of the analysis due to insufficient total amount of blood collected. The practice of too many blood cultures increases the risk of false positive (presence of contaminating bacteria), generates extra work for healthcare personnel (and laboratory) and represents a significant cost for an unproven benefit.

The investigators propose to evaluate a single blood culture sampling technique with seeding 4 vials (2 aerobic and anaerobic 2).

详细描述

Blood cultures will be collected from patients admitted with on of the following signs: fever (≥38.5°C), hypothermia (≤36°C), chills or shock. For the first blood culture, 40 mL of blood will be obtained aseptically by a single phlebotomy and equally distributed into two BacT/Alert FA aerobic bottles and two BacT/Alert FN anaerobic bottles (bioMérieux, La-Balme-les-Grottes, France). The four bottles will be labelled from one to four in the following order: aerobic-anaerobic-aerobic-anaerobic. Within the next 24 h, one to three other 20-mL blood cultures consisting of a single pair of aerobic and anaerobic bottles will have to be performed, spaced by a minimum of 30 minutes. Bottles will be incubated for 5 days or until positivity reported by the BacT/Alert 3D instrument.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • Patient who is at least 18 years
  • Patients admitted to an emergency department of a three CHU Caen, Lille, Rouen
  • Patient with clinical justifying the realization of blood cultures (as good practice recommendations)
  • Patients who received information about the study or if his legal representatives or his close entourage
  • Patient not objecting to the venipuncture

排除标准

  • Patient who direct venipuncture is impossible
  • Patient refusing venipuncture
  • Patient aged under 18
  • Patient with impaired vigilance and not accompanied by a family member or a trusted person may receive clear information protocol
  • Vulnerable Patient and not accompanied by a family member or a trusted person may receive clear information protocol

结局指标

主要结局

Rate of pathogens identified by each strategy

时间窗: baseline

次要结局

  • Proportion of blood cultures contaminated in each strategy(baseline)

研究者

申办方类型
Other
责任方
Sponsor

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