Performance Assessment of 7 Biomarkers for the Diagnosis of Severe Bacterial Infections in Children Aged From 7 Days to 36 Months.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 983
- 试验地点
- 3
- 主要终点
- Diagnosis of severe bacterial infection (SBI)
研究概览
简要总结
ANTOINE is a prospective trial which aims to assess diagnostic performance of 7 biomarkers for the diagnosis of severe bacterial infections (SBI) in children aged from 7 days to 36 months.
Fever is a frequent cause of consultation in pediatric emergency departments. Clinical diagnostic tools are rare and discrimination between severe bacterial infection and viral infection is difficult to confidently state. The prevalence of severe bacterial infections (IBS) varies from 10 to 25% according to the studies. Biological markers such as procalcitonin (PCT) and C-reactive protein (CRP) are commonly used in clinical practice. These markers have bacterial specificity but share a wide range of values with viral infections and do not make it possible to exclude or to confirm definitively the diagnosis of IBS. The use of new markers to improve the diagnosis of bacterial and viral infections is increasingly studied in adults. The diagnostic value of these new markers has been demonstrated by associating their dosage with that of CRP for example. This is the case for IP-10, TRAIL or MxA. However, very few pediatric studies have been carried out to date on these new biomarkers. However, in pediatrics, these diagnostic tools based on the combination of biomarkers to discriminate against viral and bacterial infections could be a major help in the suspicions of IBS. 7 biomarkers were selected to be evaluated in this study. This study is designed to determine the best biomarkers combination for the SBI diagnosis on a cohort of 800 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Febrile children:
- •Between 7 days and 3 months old : fever >38°C for more than 6 hours (late neonatal fever suspected) for which the physician prescribed venipuncture
- •Between 3 months and 36 months old : fever ≥38,5°C for more than 6 hours and less than 7 days for which the physician prescribed venipuncture for suspected severe bacterial infection
- •Patient with national health cover
- •Consent form signed by at least one parent
排除标准
- •Children treated by antibiotherapy within the past 48h
- •Children with congenital or acquired immunodeficiency syndrome or long-term immunosuppression treatment
- •Vaccinated children within 48h by an inactivated vaccine or within 10 days for the MMR vaccines
- •Children with a chronic disease
- •undergoing surgery within 7 days before inclusion
研究组 & 干预措施
7 biomarkers combination
干预措施: Diagnostic performances of a combination of biomarkers (Biological)
结局指标
主要结局
Diagnosis of severe bacterial infection (SBI)
时间窗: at Day 7
Diagnostic performance of the biomarkers combination will be compared to the diagnostic performances of CRP alone and PCT alone, based on the adjudication committee classification (gold standard). The Adjudication Committee will sort patients in 6 different groups according to their clinical data: (1) proved SBI, (2) presumed SBI, (3) both viral \& bacterial infection, (4) proved viral infection, (5) presumed viral infection, \& (6) not classifiable patient. To answer the primary outcome, the SBI class will group proved SBI (1), presumed SBI (2) and both viral \& bacterial infection (3).
次要结局
- Diagnosis of viral infection(at Day 7)
- Unfavorable evolution(at Day 7)