Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,426
- 试验地点
- 18
- 主要终点
- Evaluate the adverse events profile of each patient
研究概览
简要总结
This treatment protocol will enable therapeutic use of Anascorp in the management of systemic manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise be unavailable. The working hypotheses are as follows:
- The investigational antivenom is safe as treatment of scorpion sting envenomation.
- The investigational antivenom is effective as treatment of scorpion sting envenomation.
详细描述
The purpose of this Open Label, Multi-Center Treatment Protocol, phase III trial is to examine the safety and efficacy of Anascorp, for treatment of patients envenomed by scorpion sting.
The treatment protocol, including up to 25 Arizona sites, increases the total number of subjects receiving Anascorp™, and can provide supplemental safety data for the review process. At the same time, it will prevent a public health crisis in rural Arizona by replacing the dwindling supply of local antivenom before an BLA is approved.
Patients who arrive at the emergency clinic presenting with scorpion sting symptoms will be evaluated for treatment with Anascorp.
Each patient who qualifies for entry into the study, according to inclusion/exclusion criteria, is assigned a patient number in sequential order of entry. Approximately 100 patients could be enrolled in the study per year.
After informed consent has been obtained, a baseline history and physical will be obtained and documented in the patient's chart. This will include an evaluation of the symptoms of systemic scorpion envenomation. The patient's vital signs (blood pressure, pulse and respiration) will be taken. The patient will be questioned as to concomitant medications. Demographic data will also be collected.
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
- •Males and females of any age presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation
- •Signed written Informed Consent by patient or legal guardian
排除标准
- •Allergy to horse serum
研究组 & 干预措施
1
Patients who arrive to emergency room with scorpion sting envenomation will be evaluated according to inclusion/exclusion criteria. After informed consent has been signed they will be assigned to unique treatment arm with Anascorp.
干预措施: Antivenin Centruroides (scorpion) F(ab)2 Anascorp™ (Drug)
结局指标
主要结局
Evaluate the adverse events profile of each patient
时间窗: immediately after treatment, 24 hrs and 14 days.
次要结局
- Resolution of systemic signs of scorpion envenomation(after treatment)