Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Number of bacteremia positive patients
研究概览
简要总结
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
详细描述
This protocol is intended for use by external sites collecting clinical research specimens for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on patients' medical history, blood properties, medications, and blood culture history/results are required from the T2Bacterial Assay's target patient population (i.e., candidates for blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will be collected from negative blood culture, positive non-bacteria blood culture and positive bacteria blood culture patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
- •Males and females 18 - 95 years of age.
- •For Group A,
- •Subject is confirmed to have bacteremia (gram negative rods, gram negative coccobacillus, and/or gram positive cocci) as evidenced by a positive diagnostic blood culture
- •Subsequent species identification identifies the presence of one of the following 6 species of bacteria:
- •Acinetobacter baumannii
- •Staphylococcus aureus
- •Klebsiella pneumonia
- •Pseudomonas aeruginosa
- •Enterococcus faecalis
- •Enterococcus faecium
- •For Group B,
- •Males and females 18 - 95 years of age.
- •Subject is confirmed to not have bacteremia from the 6 bacteria species targeted by this study, as evidenced by diagnostic blood culture and subsequent species identification.
排除标准
- •Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
- •Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
- •Subject has had an anti-bacterial drug administered through the same port or central line as is used to collect the clinical research specimens. A line draw cannot be used to obtain a study sample if an antibacterial agent was administered intravenously within the last 72 hours, unless the site can specifically document that a different line was used to administer the anti-bacterial agent.
结局指标
主要结局
Number of bacteremia positive patients
时间窗: 3-5 days post blood culture
Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal
次要结局
- Number of bacteremia negative patients(3-5 Days post blood culture)