Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Validation of use of HBP in evaluation of patients with suspected infection
研究概览
简要总结
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.
详细描述
Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission.
Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken.
The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.
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
- 否
入选标准
- •>18 years of age,
- •Suspected infection (temperature >38C or clinical evidence of infection),
- •intention by clinician to start antibiotics
排除标准
- 未提供
结局指标
主要结局
Validation of use of HBP in evaluation of patients with suspected infection
时间窗: 12 months
次要结局
未报告次要终点
