Clinical Evaluation To Determine The Expected Values Distribution Of Procalcitonin For The RAMP® Procalcitonin Test In A Healthy Reference Population (PRO-H)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Procalcitonin value for healthy reference subjects
研究概览
简要总结
Prospective, single-centre study in healthy volunteers to establish a reference range for the RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the reference range for measurement of PCT levels using the RAMP Procalcitonin test.
详细描述
Healthy volunteers who meet eligibility criteria and have provided informed consent will be enrolled in this study. Each participant will be required to donate 1 blood sample via standard venipuncture into an EDTA (lavender top) tube for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. Sample collection will take place within a single clinical session. The maximum trial duration for each participant is one clinic session.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Apparently healthy (as determined by a subject questionnaire) males or females, of any race
- •>18 years of age
- •Willing to voluntarily agree to sign a consent form
排除标准
- •Meets the definition for one or more of Systematic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock and/or Multiple Organ Dysfunction Syndrome (MODS) as defined by The American College of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM) consensus conference in
- •Current diagnosis, or history, of any underlying major medical condition such as heart disease, hypertension/hypotension, stroke, renal disease, chronic obstructive pulmonary disorder, diabetes, bleeding disorders, hypercalcitoninemia, HIV, etc.
- •Bacterial, fungal or malaria infection within previous 12 months
- •Have experienced or undergone trauma, surgery, cardiac shock and/or a burn within previous 3 months
- •Current diagnosis of cancer and/or has undergone Immunotherapy which stimulates cytokines in the previous 12 months
- •Hospitalization (for >24 hours) within previous 3 months
- •Currently pregnant or nursing a child
- •Unable, or unwilling, to provide required blood sample for testing
- •Non-compliance to the protocol or inclusion criteria
- •Investigator believes subject is unsuitable for inclusion in the trial (i.e. has major condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study)
结局指标
主要结局
Procalcitonin value for healthy reference subjects
时间窗: Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.
Procalcitonin value for each subject will be determined within 2 hours of phlebotomy. At study completion all data obtained will be compiled and a 95th percentile value determined.
次要结局
未报告次要终点