NCT00739440已完成4 期
Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.0 个研究点目标入组 120 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Resolution of signs and symptoms of scorpion envenomation
研究概览
简要总结
The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum
详细描述
We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.
This is a randomized clinical trial, which included 120 subjects of both sexes aged 15 and 60 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sting scorpion
- •Informed consent
- •Age 15-60
- •Either sex
- •Resident in study area
排除标准
- •Previous treatment with gammaglobulin
- •Blood transfusion at any stage of life
- •Sensitivity or intolerance to serums antiscorpion or horse products
- •Pregnancy
- •Some immunodeficiency
结局指标
主要结局
Resolution of signs and symptoms of scorpion envenomation
时间窗: after treatment (expected average of 12 hrs)
次要结局
- Evaluate the adverse events in every treated child(inmediately after treatment and until 5 days later)
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