A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 47
- 主要终点
- efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.
研究概览
简要总结
The purpose of this study is planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia(MPP) .
详细描述
Corticosteroid has been used in adulthood refractory MPP with satisfactory efficacy. But there were few studies about the use of corticosteroid in children with refractory MPP. Lee KY et al indicated oral prednisolone of 1 mg/kg/ day for 1 week be useful for children with severe MPP. Akihiro T et al demonstrated that intravenously administered methylprednisolone at a dose of 30 mg/kg once daily for 3 consecutive days had an efficacious treatment for children with refractory MPP.But the methods of corticosteroid use, such as the dosage, administration route, duration of treatment have not been well understood. So in this study, we planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia in a prospective, open-label fashion.
PMID: 11096025 PMID: 18033831 PMID: 10434547 PMID: 16437541 PMID: 18656264
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mycoplasma pneumoniae pneumonia
- •prolonged fever and deterioration of radiological findings despite macrolides treatment for 7 days or more.
排除标准
- •chronic cardiac and pulmonary disease
- •immunodeficiency
- •requiring mechanical ventilation
- •with other pathogens detected during pneumonia.
研究组 & 干预措施
methylprednisolone
methylprednisolone pulse azithromycin
干预措施: methylprednisolone (Drug)
azithromycin
azithromycin
干预措施: azithromycin (Drug)
结局指标
主要结局
efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.
时间窗: 3-year
compare the temperature , infiltration absorption,atelectasis resolution, pleural effusion disappearance,serum levels of ferritin and LDH between methylprednisolone pulse macrolide therapy group and macrolide therapy group .
次要结局
- safety of methylprednisolone pulse macrolide therapy for children with refractory MPP.(3-year)