跳至主要内容
临床试验/NCT00800488
NCT00800488已完成不适用

Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 2,209 人开始时间: 2008年10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
2,209
试验地点
1
主要终点
Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections

研究概览

简要总结

The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.

2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.

Evaluation of the area under the ROC for Procalcitonin concentration.

详细描述

Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.

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
7 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant older than 7 days old and less than 3 months old.
  • Fever (defined by a rectal temperature greater than or equal to 38°C)
  • Emergency consultation

排除标准

  • Infants with a previously identified immunodeficiency or chronic disease,
  • Antibiotic treatment within the previous 48 hours

结局指标

主要结局

Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections

时间窗: At the day of emergency consultation for fever

次要结局

  • Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin(At the day of emergency consultation for fever)
  • Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin(At the day of emergency consultation for fever)
  • Diagnostic value (sensibility and specificity) of CRP versus procalcitonin(At the day of emergency consultation for fever)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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