NCT05631405招募中不适用
Efficacy of Dengue Infection With Warning Signs Treated With Dexamethasone
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
The goal of this randomized double-blinded placebo-controlled trial is to learn about dexamethasone and the treatment of severe dengue population. The main question it aims to answer are steroid therapy may be effective in dengue.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Laboratory confirmed Dengue infected patients (Positive NS1 Ag or anti-DENV IgM by Dengue Duo test)
- •And still in febrile phase (Body temp>37.5 C)
- •Shock : Sys<90mmHg or Narrow PP (<20mmHg) orTachycardia (pulse>100/min) with Hematocrit decreased ≥20 %
- •Fluid accumulation and respiratory distress
- •Severe bleeding
- •Severe organ involvement
排除标准
- •Severe dengue> 24 hrs
- •Dengue without warning signs
- •Pregnancy
- •Patient who receieved any steroid within 1 week
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Intervention
Experimental
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Mortality
时间窗: 28 days
The use of steroids in dengue will reduce mortality in rate
次要结局
- Length of hospital stay(28 days)
研究者
Nattachai Srisawat ,M.D.
Principal investigator
Chulalongkorn University
研究点 (2)
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