A Multi-center, Prospective, Pilot Study to Validate the Diagnostic Accuracy and Assess the Potential Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department With Respiratory Tract Infection (RTI) or Fever Without Source (FWS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,140
- 试验地点
- 2
- 主要终点
- To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS
研究概览
简要总结
This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™. Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.
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
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legal guardian signs an informed consent
- •Documented peak temperature ≥ 38°C (100.4°F)
- •Symptom duration ≤ 7 days
- •Clinical suspicion of RTI (OR) fever without a clear source after clinical examination
排除标准
- •Another episode of febrile infection within the past 2 weeks
- •Antibiotic treatment of over 48 hours
- •Congenital immune deficiency (CID)
- •A proven or suspected HIV, HBV, HCV infection
- •Active malignancy
- •Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
- •Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks
- •Monoclonal antibodies, anti-TNF agents
- •Intravenous immunoglobulin (IVIG)
- •Cyclosporine, Cyclophosphamide, Tacrolimus
- •G/GM-CSF, Interferons
- •Other severe illnesses that affect life expectancy and/or quality of life such as:
- •Severe psychomotor retardation
- •Post-transplant patients
- •Severe congential metabolic disorder
结局指标
主要结局
To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS
时间窗: 0-7 days after the initiation of symptoms
次要结局
- To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis(0-7 days after the initiation of symptoms)
- To compare the diagnostic accuracy of a host-response based diagnostic to currently available lab measures (WBC, ANC, CRP and PCT), using sensitivity and specificity measures and predetermined cutoffs(0-7 days after the initiation of symptoms)