Personalised Risk Assessment in Febrile Illness to Optimise Real-life Management Across the European Union (PERFORM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7,247
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically-assigned Retrospective Phenotype
研究概览
简要总结
Childhood fever is a prevalent problem. Most febrile children who visit hospital improve without treatment, but a minority require treatment, and a few will have severe disease. The investigators want to improve the diagnosis and management of febrile children by developing tests to distinguish between bacterial and viral disease so that antibiotic treatment can be initiated promptly and only when required. Judicious and prudent use of antibiotics will reduce the likelihood of developing resistant organisms and save treatment costs.
The investigators will prospectively recruit acutely febrile children presenting to hospital, collecting research samples for validation of biomarkers, in combination with clinical phenotypic markers and host genetic markers (BIVA-studies).
Any febrile child newborn to under 18 presenting to hospital will be eligible for recruitment. The study will last 5 years.
详细描述
The problem to be addressed:
Fever is among the commonest symptoms for which parents consult health care providers worldwide. Distinction between life-threatening bacterial infection and viral infection is clinically difficult, and many children worldwide receive unnecessary antibiotic treatment, or undergo invasive investigations and hospitalization, whilst bacterial infection is missed in others.
Objective:
The investigators aim to validate biomarkers that will identify children with bacterial infection, viral infection and inflammatory syndromes, using whole-blood RNA expression, proteomic and metabolomics signatures. The investigators aim to assess how efficacious these biomarkers would be if they formed the basis of a diagnostic test.
Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children <18 years with fever >38ºC, or a history of fever (within 3 days), in whom the attending clinician determines the need for blood sampling or whom parents give consent for bloods taken for research purposes
- •All children <18 years suspected of infection, including the full spectrum of disease severity and co-morbidities.
- •Afebrile control children who are having blood tests for reasons other than for investigation of infectious or inflammatory illness.
排除标准
- •Children from whom parent/legal guardian signed consent is not received
- •For healthy control children only: febrile illness or vaccination within the last 3 weeks.
结局指标
主要结局
Number of Participants With Clinically-assigned Retrospective Phenotype
时间窗: Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 days
Clinically-assigned retrospective phenotype, according to the cause of illness
次要结局
未报告次要终点