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临床试验/NCT01631916
NCT01631916撤回不适用

Use of Corticosteroids in Children Hospitalized With Community-acquired Pneumonia

Hospital General de Niños Pedro de Elizalde1 个研究点 分布在 1 个国家开始时间: 2015年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Length of stay

研究概览

简要总结

The purpose of this study is to determine the efficacy of addition of corticosteroid therapy to antibiotics in children hospitalized with community-acquired pneumonia.

The hypothesis is that the use of corticosteroids decreases the length of stay in children hospitalized with community-acquired pneumonia.

详细描述

Community-acquired pneumonia (CAP) is a common problem in pediatric practice. The lower respiratory tract infections, particularly pneumonia, are a frequent cause of morbidity in children and is the leading cause of mortality in developing countries.

In the last 20 years, despite several research, only a small decrease in morbidity and mortality has been achieved.

Corticosteroids have an immune-modulation effect, not completely elucidated. Most likely, this effect is due to down regulation of pro-inflammatory cytokines.

We postulate that adding corticosteroids to antibiotic treatment of CAP might change the immune response and thereby reduce morbidity, leading to a decrease in patients hospital length of stay.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children hospitalized for community-acquired pneumonia
  • 2-18 years old

排除标准

  • Pulmonary chronic disease (including asthma)
  • Immunodeficiency
  • Diseases wich requires corticosteroids therapy (i.e. rheumatic diseases)
  • Wheezing in current disease
  • Previous hospitalization (14 days prior to admission)
  • Pleural effusion on admission
  • Malnutrition

研究组 & 干预措施

Corticosteroid

Experimental

Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day

干预措施: corticosteroid (Drug)

结局指标

主要结局

Length of stay

时间窗: participants will be followed for the duration of hospital stay, usually 5 days

次要结局

  • Length of fever(participants will be followed for the duration of hospital stay, usually 5 days)
  • Length of oxygen use(participants will be followed for the duration of hospital stay, usually 5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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