An Observational Study to Evaluate the Diagnostic and Predictive Accuracy of the Mologic Biomarker Panel in Patientsrnwith Severe Infection
试验速览
- 阶段
- 不适用
- 发起方
- Mologic Ltd
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Biomarkers and results from routine clinical testing for infection
研究概览
简要总结
This study is a prospective, single center, observational, cohort study of patients to determine whether the Mologic Biomarker Panel can identify patients with infection from those without, including those with other reasons for inflammation (e.g. post-operative). It will also assess whether it has the potential to judge the severity of illness, prognosticate outcome and guide antibiotic therapy.
The aim is to recruit patients who are "representative" of patients with suspected sepsis, uncomplicated infection, or non-infection related critical illness that require critical care intervention and assessment.
This study is observational and will not alter patient management or the standard of care. The results from the investigational Mologic Biomarker Panel and associated research assays will not be provided to treating clinicians, or used in any manner to affect patient care.
The study will take place over approximately an 18-month period and it is anticipated that approximately 600 patients will be collectively enrolled. The study aims to recruit patients from three environments within UCLH:
- The Emergency Department.
- Critical Care Unit
- Patients undergoing major surgery
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 old
- •Investigated for potential infection (the clinical need for a blood culture)
排除标准
- •<18 years old
- •Severe anaemia (<60g/dl) and contra-indication to transfusion
- •Unable to gain consent or agreement
- •Treated with palliative intent
- •Blood culture indicated for screening or monitoring
结局指标
主要结局
Biomarkers and results from routine clinical testing for infection
时间窗: 18 months
Research assay will be used to test for the investigational Mologic biomarker panel and these results will be assessed using the results obtained from conventional testing used to identify infection (such as white cell count and CRP), in order to find a clinical association with the mologic biomarkers and patients with infections.
次要结局
未报告次要终点