CTRI/2015/11/006360进行中（未招募）4 期
A study to assess the role of early dexamethasone therapy in prevention of morbidity and mortality in children aged 6months to 12 years with pyogenic meningitis
Kolkata Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2015年11月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
This study is a randomised, double blind, parallel group single centre trial. It is an add-on study since both the group will receive the standard therapy.
the trial evaluates the efficacy of early dexamethasone therapy o.15mg/kg
/dose QDS for 4days before or along with antibiotic therapy in a case of pyogenic meningitis. the study is conducted in paediatric department of Kolkata medical college, west Bengal, India. The primary outcome measures will be mortality within 3weeks of treatment and secondary outcomes will be developement of seizure disorder at 3months and hearing impairment at 6 months after the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Any patient of 6 months to 12years of age with clinical manifestations of acute meningitis, CSF profile consistent with bacterial meningitis.
- •2.Confirmed pathogen by blood or CSF culture.
排除标准
- •1Patient’s age less than 6 months or more than 12years.
- •2Where CSF analysis is not done or CSF profiles were not compatible with bacterial meningitis are to be excluded.
- •3Neonatal maninigitis .
- •4Patients received antibiotics outside before admission.
- •6 any patient with a congenital or acquired abnormality of the central nervous system 7 a prosthetic device inserted into the central nervous system 8 previous episodes of bacterial meningitis 9 an underlying neurologic abnormality 10 a history of hypersensitivity to beta-lactam antibiotics are excluded.
结局指标
主要结局
Mortality
时间窗: 3weeks
次要结局
- Developement of seizure disorder(3months)
- Hearing impairment(6months)
研究者
研究点 (1)
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