NCT01525095已完成不适用
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 5
- 主要终点
- Number of Candida Positive patients
研究概览
简要总结
The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.
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.
- •For Group A,
- •Males and females 18 - 95 years of age.
- •Subject is confirmed to have fungemia as evidenced by a positive diagnostic blood culture and subsequent species identification.
- •For Group B,
- •Males and females 18 - 95 years of age.
- •Subject is hospitalized with a medical problem other than fungemia, or is being treated as an outpatient for some non-infection-related condition, and
- •Subject is confirmed to not have fungemia 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.
结局指标
主要结局
Number of Candida Positive patients
时间窗: 3-5 days post blood culture
Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal
次要结局
- Number of Candida Negative Patients(3-5 days post blood culture)
研究者
研究点 (5)
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