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临床试验/NCT01041209
NCT01041209已完成不适用

Efficacy of BPS (Bacterial Pneumonia Score) Guided Antibiotic Use in Children With Community Acquired Pneumonia on Reducing Antibiotic Use as Compared to Standard Care Practice (Current Guidelines for CAP)

Hospital General de Niños Pedro de Elizalde2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年3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
120
试验地点
2
主要终点
Use of Antibiotics in Each Group

研究概览

简要总结

The aim of this study is to test if BPS (Bacterial Pneumonia Score) guided antibiotic use in children with non severe community acquired pneumonia (CAP) will reduce antibiotic use as compared to standard care practice (current guidelines for CAP).

详细描述

Background: Pneumonia is a leading cause of mortality in children. Despite more than 50% of pneumonias are due to viruses, because it is difficult to rule out bacterial etiology, initial management of pneumonia in children usually includes antibiotics, often unnecessary. In 2006 was designed and validated a clinical prediction rule (BPS: Bacterial Pneumonia Score) which accurately identifies hospitalized children's risk of bacterial pneumonia. However, BPS efficacy on guiding therapeutic decision in children with community acquired pneumonia (CAP) has not been yet assessed.

Aim: The aim of this study is to test if BPS guided antibiotic use in children with non severe community acquired pneumonia will reduce antibiotic use as compared to standard care practice (current guidelines for CAP) Design: This is a randomized, controlled, blinded trial, to assess antibiotics use regarding two methods for initial management of children aged 3-60 months with non severe community acquired pneumonia. Children will be randomly allocate to be managed according to BPS or currently enforced guidelines. Use of antibiotics (%) and clinical outcome of both groups will be compared.

Setting: Tertiary children hospital in Buenos Aires, Argentina. Patients: Consecutive children aged 3-60 months assisted for non severe community acquired pneumonia as outpatients. Patients with wheezing, severe pneumonia, pulmonary or cardiovascular chronic disease, or antibiotic use or hospitalization in the previous two weeks will be excluded.

Endpoints:

Primary: Use of antibiotics in each group (proportion) Secondary: Treatment failure (proportion) in each group Endpoints will be assessed at baseline and after 1, 2, 5, 7 and 10 days by a blinded investigator.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Months 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3-60 months assisted as outpatients for non severe community acquired pneumonia.

排除标准

  • Severe pneumonia
  • Pulmonary or cardiovascular chronic disease
  • Antibiotic use in the previous two weeks
  • Hospitalization for any reason in the previous two weeks

结局指标

主要结局

Use of Antibiotics in Each Group

时间窗: At baseline

The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).

次要结局

  • Treatment Failure in Each Group(1, 2, 5, 7 and 10 days from baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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