Multicenter Safety Evaluation of Human Rabies Immune Globulin 300 IU/mL in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration
研究概览
简要总结
This observational study will be conducted across the Houston Methodist system, including all hospital-based and freestanding emergency departments (ED), and up to 4 additional sites in the United States. The safety of human rabies immune globulin (HRIG) 300 IU/mL product (HyperRAB®) in pediatric patients has not been fully established. The purpose of this study is to evaluate the safety of HRIG 300 IU/mL when given to pediatric patients per standard of care for rabies postexposure prophylaxis (PEP) in the ED.
详细描述
BACKGROUND: Rabies PEP consists of thorough wound cleansing, administration of HRIG 20 IU/kg body weight, and 4 to 5 doses of rabies vaccine. The safety of HRIG 300 IU/mL has been confirmed only for adult patients. Although the safety of HRIG 300 IU/mL in the pediatric population has not been fully established, there is no age limit on the FDA approved indication for HRIG 300 IU/mL, and it is routinely administered to pediatric patients as standard of care in the United States.
STUDY DESIGN: This observational, multicenter, prospective study will collect information on safety events that occur up to 30 days after standard of care administration of HRIG 300 IU/mL among pediatric patients (age ≤17 years) at up to 5 study sites in the United States. Safety data will be collected using surveys and chart review of the health record. All participants will receive HRIG 300 IU/mL per standard of care prior to joining this study. The day of HRIG 300 IU/mL administration will be defined as day 0. The study will conduct Survey 1 on day 2 and Survey 2 on day 10 to collect information on adverse events (AEs). Investigators will review the electronic health record on day 30 to collect additional information on AEs. If a serious adverse event is detected during Survey 1, Survey 2, or the 30-day chart review and is not previously documented as being resolved or stabilized the study will conduct Survey 3 on day 30.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of local and systemic adverse events (AEs) within 2 days of HRIG 300 IU/mL administration
时间窗: Within 2 days of HRIG 300 IU/mL administration
Proportion of patients with 1 or more AEs deemed as possibly/definitely related to HRIG 300 IU/mL administration
次要结局
- Cumulative incidence of all local and systemic AEs within 30 days of HRIG 300 IU/mL administration(Within 30 days of HRIG 300 IU/mL administration)
- Cumulative incidence of all local and systemic AEs within 10 days of HRIG 300 IU/mL administration(Within 10 days of HRIG 300 IU/mL administration)
- Cumulative incidence of all local and systemic serious adverse events (SAEs) within 30 days of HRIG 300 IU/mL administration(Within 30 days of HRIG 300 IU/mL administration)
- Type and severity of individual local and systemic AEs detected within 30 days of HRIG 300 IU/mL administration(Within 30 days of HRIG 300 IU/mL administration)
研究者
Michael Sirimaturos
Administrative Specialist - System Critical Care Services Leader
The Methodist Hospital Research Institute