NCT02552342Unknown4 期
Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 610
- 试验地点
- 1
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of the present study is to assess the efficacy of methylprednisolone as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).
The hypothesis of the study is that methylprednisolone can decrease the mortality of severe CAP without any significant side effects,with reduction of the time to clinical stability and failure rate of treatment.
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
- Triple (Participant, 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
- 否
入选标准
- •community-acquired pneumonia
- •PSI score：4-5
- •with at least one of following conditions：①CRP ≥150 mg/L,②oxygen index ≤250 , ③bilateral or multi-lober infiltrates in chest image,④ area of pulmonary infiltrates increase >50% with 48 hous,⑤fever higher than 39℃ exceed 72 hours
排除标准
- •nosocomial Pneumonia
- •aspiration pneumonia
- •acute burn injury
- •gastrointestinal bleeding within the past three months
- •uncontrolled diabetes mellitus
- •pregnant or breast feeding
- •a condition requiring treatment with greater than 0.5 mg/kg/d of prednison or its equivalent
- •severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
- •active tuberculosis
- •preexisting medical condition with a life expectancy of less than 3 months
研究组 & 干预措施
methylprednisolone
Active Comparator
This group was entitled to receive methylprednisolone 80mg/day for 3 days，then 40mg/day for 3 days
干预措施: methylprednisolone (Drug)
Placebo
Placebo Comparator
This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug
干预措施: Normal saline (Drug)
结局指标
主要结局
All cause mortality
时间窗: 30-days
次要结局
未报告次要终点
研究者
研究点 (1)
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