Botulinum Antitoxin Patient Registry for the Evaluation of Safety and Clinical Outcomes of Pediatric and Adult Patients Following BAT Treatment for Confirmed or Suspected Exposure to Botulinum Toxin.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 主要终点
- Number of participants with serious and non-serious adverse events
研究概览
简要总结
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to botulinum toxin.
详细描述
A full description of the patient registry can be found in the paper titled: Safety and Clinical Outcomes of an Equine-derived Heptavalent Botulinum Antitoxin Treatment for Confirmed or Suspected Botulism in the United States. Richardson JS, Parrera GS, Astacio H, Sahota H, Anderson DM, Hall C, Babinchak T. Clin Infect Dis. 2019 Apr 15;70(9):1950-1957.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient of any age [age category: pediatric-newborn infants (0 to 27 days), infants and toddlers (28 days to 23 months), children (2 to 11-years), and adolescents (12 to <17-years); adult (17-64-years); and geriatric (≥65-years)] with a confirmed or suspected exposure to botulinum toxin who were treated with BAT® provided by the CDC.
排除标准
- 未提供
研究组 & 干预措施
Participants treated with BAT®
Any patient of any age with a confirmed or suspected exposure to botulinum toxin who were treated with BAT®.
干预措施: BAT (Drug)
结局指标
主要结局
Number of participants with serious and non-serious adverse events
时间窗: From BAT® administration up to discharge from hospital (200 days)
The data obtained will more clearly define the absolute risk (incidence rates) of hypersensitivity/allergic reactions, including serum sickness, febrile reactions, hemodynamic instability, bradycardia, and other serious adverse events in pediatric and adult patients that are treated with BAT® due to a confirmed or suspected case of botulism.
次要结局
未报告次要终点