Effects and Safety of Caspofungin and Corticosteroids in Pneumocystis Pneumonia in Non-HIV Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
Pneumocystis Pneumonia is increasing in Immunocompromised Non-HIV Infected Patients. The effects and safety of caspofungin and corticosteroids is not certain in this population. All Immunocompromised Non-HIV patients with respiratory failure were randomized into caspofungin and non-caspofungin group and corticosteroids and non-steroids group. The major outcome is 28 day mortality, the second outcome are time of respiratory rate decreases to less than 25 breath per minute, body temperature lower than 37.3℃.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunocompromised Non-HIV Infected Patients
- •Partial arterial O2 pressure(PaO2)/FiO2≤300mmHg
- •Diagnosed as Pneumocystis Pneumonia
排除标准
- •younger than 16 years old
- •severe organ failure
- •allergic to sulfanilamide, caspofungin or corticosteroid
研究组 & 干预措施
Caspofungin and corticosteroids
patients treat with caspofungin and corticosteroids on the base of sulfanilamide
干预措施: caspofungin (Drug)
Caspofungin and corticosteroids
patients treat with caspofungin and corticosteroids on the base of sulfanilamide
干预措施: corticosteroids (Drug)
Caspofungin and corticosteroids
patients treat with caspofungin and corticosteroids on the base of sulfanilamide
干预措施: Sulfanilamides (Drug)
Caspofungin and no corticosteroids
patients treat with caspofungin on the base of sulfanilamide
干预措施: caspofungin (Drug)
Caspofungin and no corticosteroids
patients treat with caspofungin on the base of sulfanilamide
干预措施: Sulfanilamides (Drug)
corticosteroids and no caspofungin
patients treat with corticosteroids on the base of sulfanilamide
干预措施: corticosteroids (Drug)
corticosteroids and no caspofungin
patients treat with corticosteroids on the base of sulfanilamide
干预措施: Sulfanilamides (Drug)
no corticosteroids and no caspofungin
patients treat with sulfanilamide only
干预措施: Sulfanilamides (Drug)
结局指标
主要结局
mortality
时间窗: 28 days
次要结局
- Time for release of fever(2 days)
- Time for release of respiratory distress(2 days)
研究者
Hangyong He
Doctor
Beijing Chao Yang Hospital