Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 2
- 主要终点
- Antibiotic Prescription Rate
研究概览
简要总结
Detecting serious bacterial infections (SBI) in children presenting to the Pediatric Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic challenge. The recently described Lab-score, based on the combined determination of Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in children with FWS, and to prospectively determine the diagnostic characteristics of the Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count, band count and CRP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 7 days to 3 years old
- •fever without source ≥ 100.4°F (≥ 38.0°C)
排除标准
- •antibiotics received in the previous 48 hours
- •underlying congenital or acquired immunodeficiency syndrome
- •fever for more than 7 days at presentation
结局指标
主要结局
Antibiotic Prescription Rate
时间窗: at PED (Pediatric Emergency Department) presentation
次要结局
- Specificity of a Lab-score ≥ 3(at 72 hours from PED presentation)
- Presence of Serious Bacterial Infection(at 72 hours from PED presentation)
- Hospitalization Rate(at PED presentation)
- Sensitivity of a Lab-score ≥ 3(at 72 hours from PED presentation)
- Sensitivity of Standard Biological Marker for SBI(at 72 hours from PED presentation)
- Specificity of Standard Biological Marker for SBI(at 72 hours from PED presentation)
研究者
Laurence Lacroix
Dr
University Hospital, Geneva