The CAPISCE-Trial: Community-Acquired Pneumonia; an Intervention Study With Corticosteroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- Clinical efficacy at the end of treatment
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 patient admitted with Community-acquired pneumonia.
The hypothesis is: Prednisolone in combination with antibiotic treatments is effective in improving clinical outcome in patients hospitalized with CAP.
详细描述
Community-acquired pneumonia (CAP) is a acute illness with a considerable morbidity and mortality, especially patients with severe CAP. In the past decennia, in spite of many investigations, little reduction is seen in morbidity an mortality. Corticosteroids have a immune-modulation effect, which is not completely elucidated. Most likely the immune modulation effect is due to down-regulation of pro-inflammatory cytokines. The use of corticosteroids next to antibiotics in CAP could lead to shorter time to clinical stability, length of stay and costs.
Comparison: Hospitalized patients with CAP treated with antibiotics and prednisolone versus hospitalized patients with cap treated with antibiotics and placebo
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical symptoms of community-acquired pneumonia:
- •Fever, cough, sputum, pleural pain, dyspnoea
- •Radiological symptoms of pneumoniä
排除标准
- •Any conditions wich requires corticosteroid therapy.
- •Pregnancy of lactation
- •Malignancy
- •Immune-compromised patients (eg chemotherapy or AIDS)
- •Pre-treatment with macrolide for >24 hours
结局指标
主要结局
Clinical efficacy at the end of treatment
次要结局
- Clinical efficacy at follow up
- Inflammation response (serummarkers)
- Length of Stay
- Time to clinical stability
- Mortality
- Time to defeverescence