NCT07107932招募中不适用
A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 4
- 主要终点
- Primary Outcome
研究概览
简要总结
The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.
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
- •1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;
- •2. Provided signed informed consent by themselves or their legal representatives.
排除标准
- 未提供
研究组 & 干预措施
Siltartoxatug Injection (Brand name: Sintetol®)
干预措施: Siltartoxatug Injection (Brand name: Sintetol®) (Drug)
结局指标
主要结局
Primary Outcome
时间窗: within 90 days
Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)
次要结局
- Secondary Outcome(within 90 days)
研究者
研究点 (4)
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