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临床试验/NCT00471640
NCT00471640已完成不适用

Dexamethasone Infusion in Community-acquired Pneumonia

St. Antonius Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007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
已完成
入组人数
300
试验地点
2
主要终点
length of hospital stay

研究概览

简要总结

The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

详细描述

Community-acquired pneumonia (CAP) is common and approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring ICU admission.1 Especially elderly patients may have a severe illness with a high morbidity and mortality rate. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a useful mechanism in the elimination of invading pathogens. However, this natural reaction can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung.

Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Hypothetically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients aged 18 to 100 years with a community-acquired pneumonia.
  • Criteria to determine a community-acquired pneumonia:
  • Chest radiograph showing new opacities
  • In combination with two of the following findings:
  • Production of sputum
  • Temp >38,0 °C or <36,0 °C
  • Audible abnormalities by chest examination compatible with pneumonia
  • Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leukopenia (<4000 cells/mm3)
  • CRP > 15 mg/dl (three times upper limit of normal)

排除标准

  • o The following groups are excluded:
  • Immunocompromised patients:
  • Patients with a known congenital or achieved immunodeficiency.
  • Patients who received chemotherapy less than 6 weeks ago.
  • Patients who received corticosteroids in the last 6 weeks.
  • Patients who received immunosuppressive medication in the last 6 weeks. (like cyclosporine, cyclofosfamide, azathioprine)
  • Patients with COPD who are on systemic corticosteroids for COPD.
  • Patients who require ICU treatment.

研究组 & 干预措施

1

Active Comparator

dexamethasone

干预措施: dexamethasone (Drug)

2

Placebo Comparator

Placebo

干预措施: dexamethasone (Drug)

结局指标

主要结局

length of hospital stay

时间窗: 30 days

次要结局

  • side-effects inflammation markers lung function(30 days)

研究者

申办方类型
Other

研究点 (2)

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