Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- proportion of microbiologically documented infections
研究概览
简要总结
Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures.
The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.
详细描述
Evaluation criteria are 1) proportion of microbiologically documented infections 2) time elapsed from bed side sampling to microbiological diagnostic, in case of positive sample.
The assessed procedures included a large volume of blood, an early incubation made possible by the availability of a culture device in the hematology department, an early warning in case of positive blood culture, bacterial DNA detection in blood, and an early identification of the positive strains and their resistance profile.
We hypothesize that the combination of these different procedures will improve the proportion of microbiologically blood culture from 30 to 45%. One hundred and 20 episodes of febrile neutropenia are necessary to achieve this goal.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 y
- •first episode of febrile neutropenia during a given neutropenic phase
- •PMN < 500/mm3, chemotherapy-induced
- •fever > 38°C twice, or < 38°3C once
- •signed informed consent
排除标准
- •patient already receiving empirical or therapeutic antibacterial after their first episode of febrile neutropenia
结局指标
主要结局
proportion of microbiologically documented infections
时间窗: Day 14 from inclusion
次要结局
- clinical status at the end of hospitalisation(Day 30 from inclusion)