Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fever duration
研究概览
简要总结
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.
详细描述
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.
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
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of Mycoplasma pneumoniae infection
- •Lobar pneumonia or pneumoniae with pleural effusion
排除标准
- •Immunosuppresant host
- •Chronic cardiovascular/pulmonary disease
- •Hospital acquired infection
研究组 & 干预措施
Steroid
Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days
干预措施: Prednisolone (Drug)
Steroid
Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days
干预措施: Levofloxacin (Drug)
Control
Levofloxacin, 10mg/kg/day, IV, for 5days
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Fever duration
时间窗: within the first 14 days after intervention
次要结局
- Number of patients improved in chest X-ray(within the first 14 days after intervention)
- Number of patients with side effect of steroid(within the first 14 days after intervention)