跳至主要内容
临床试验/NCT02424721
NCT02424721终止不适用

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

Axis Shield Diagnostics Ltd4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年5月最近更新:
适应症

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

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

研究者

发起方
Axis Shield Diagnostics Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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