Comparing Hydrocortisone and Prednisolone for Community Acquired Pneumonia (CAP)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,600
- 试验地点
- 14
- 主要终点
- All-cause mortality
研究概览
简要总结
The goal of this cluster randomized controlled trial is to determine the optimal treatment for community aquired pneumonia (CAP). The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 18 years old diagnosed with severe CAP. The main question is whether there is a difference in all cause mortality within thirty days.
Participants will be randomized to receive treatment with either hydrocortisone or prednisolone.
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 (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
- •Age > 18 years
- •Diagnosis of severe CAP for who the physician in charge decides for corticosteroid therapy for severe CAP.
排除标准
- •Admitted >24 h
- •Pregnant or breastfeeding women
- •Active tuberculosis or fungal infection
- •Pneumonia caused by influenza
- •Intolerance to either study drug
研究组 & 干预措施
Treatment with Hydrocortisone.
This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.
干预措施: hydrocortisone (Drug)
Treatment with Methylprednisolone
This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.
干预措施: Methylprednisolone (drug) (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 30 days
次要结局
- All-cause infections(90 days)
- Gastrointestinal bleeding(30 days)
- All-cause mortality(90 days)
- Need for vasopressor treatment(30 days)
- Need for mechanical ventilation(30 days)
- Admission to ICU(30 days)
- Daily amount of insulin administered to the patient by day 7 or discharge from hospital(7 days)
- Blood glucose levels(7 days)