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临床试验/NCT02179398
NCT02179398已完成不适用

Impact of the Lab-score on Antibiotic Prescription Rate in Children Aged 7 Days to 3 Years Old With Fever Without Source.

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2010年9月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurence Lacroix

Dr

University Hospital, Geneva

研究点 (2)

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