Randomized Controlled Trial To Evaluate Efficacy And Safety Of The Polyvalent Anti-scorpion Venom Serum Of Birmex Versus Other Commercial Venom Serum In Children Population
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Resolution of signs and symptoms of scorpion envenomation
研究概览
简要总结
The morbidity associated with scorpion sting intoxication presents an endemic pattern in the country, where there are highly venomous species of scorpions so the scorpion sting intoxication (IPPA) is considered a medical emergency.
On the other hand, there is scarce scientific literature from different controlled studies evaluating anti-scorpion serum, considering clinical severity scales, lab results and their safety. The aim of this study is to compare the efficacy and safety of scorpion sting treatment, using two sera, one produced by Birmex versus Alacramyn ® (Bioclon).
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 0 and 15 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 (Alacramyn).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scorpion sting
- •Age 1 to 15 years
- •Signing an informed consent (signed by parent or guardian)
- •Being residents of the state of Guanajuato
排除标准
- •Previous treatment with gamma globulin or immunoglobulin
- •Blood transfusion at any stage of life
- •Patients treated with drugs that interact with anti-scorpion serum
- •History or history of sensitivity or intolerance to anti-scorpion serum or horse products
- •Any immunodeficiency
- •Patients who have participated in a research protocol in the previous month.
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)