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临床试验/NCT01875731
NCT01875731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) in the Era of Pneumococcal Vaccine

Hospital General de Niños Pedro de Elizalde2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2013年7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
66
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) and pneumoccocal vaccine 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. Recently, we assessed BPS efficacy on reducing antibiotic use by 50% in children with CAP, in an ambulatory setting. However, BPS was tested in children not vaccinated against S. pneumoniae.

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)in children vaccinated against S. penumoniae.

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 and pneumoccocal vaccine. 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:

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
Single (Investigator)

入排标准

年龄范围
3 Months 至 5 Years(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 and pneumoccocal vaccine and complete immunisation with pneumoccocal vaccine.

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 day 7 from baseline

Number of participants with use of any antibiotic, at any time after diagnosis

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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