Emergency Treatment of Coral Snake Envenomation With Antivenom
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 5
- 主要终点
- Number of Participants Who Survived
研究概览
简要总结
The purpose of this study is to see whether a new F(ab')2 antivenom will prevent injury and death from the bite of a coral snake.
Funding Source - FDA OOPD.
详细描述
Coral snake bites may be trivial in effect, or they may cause profound and life-threatening respiratory paralysis, depending on the severity of the envenomation. Venom toxins target the neuromuscular junction, where effects typically become apparent hours following the bite, by which time the clinical syndrome may be irreversible. Unless neurotoxicity is prevented, ventilatory paralysis may cause death or require intensive care for weeks after the bite. Prevention of paralysis, historically, has involved treating all bite victims with antivenom.
This protocol will enable the therapeutic use of a new F(ab')2 antivenom in the management of coral snake envenomation.
Following a coral snake bite, patients who meet inclusion/exclusion criteria and who provide informed consent will receive 5 vials of antivenom intravenously over no less than 30 minutes. Blood assays for venom levels and clinical assessments of neurologic status before and after treatment will be conducted and patients will be followed for 22 days for safety and survival endpoints.
The primary endpoint of this Phase 3 trial will be survival, for comparison with a historical mortality rate of 15%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any age. Presenting for emergency treatment of coral snake bite.
排除标准
- •Prior use of coral snake antivenom for this envenomation. Allergy to horse serum.
研究组 & 干预措施
Antivenom
For comparison with historical mortality rate, all patients prospectively enrolled will receive antivenom (Snake [Micrurus] North American immune F(ab')2 Equine) for treatment of coral snake bite.
干预措施: Snake (Micrurus) North American immune F(ab')2 Equine (Drug)
结局指标
主要结局
Number of Participants Who Survived
时间窗: Immediately following start of infusion (day 1) through Day 22
次要结局
- Change in Mean Venom Level From Baseline to 24 Hours(Through 24 hours)
- Change in Mean Antivenom Level From Baseline to 24 Hours(Through 24 hours)