Actively Recruiting
A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
Led by Zhuhai Trinomab Pharmaceutical Co., Ltd. · Updated on 2026-01-06
10000
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing patients who receive Siltartoxatug Injection, also known as Sintetol4, to prevent tetanus following injury. This large-sample, real-world registry aims to document injury and wound conditions and evaluate clinical outcomes related to tetanus prevention. The study focuses on collecting safety information and any adverse reactions after receiving the injection. Participants in this observational study receive Siltartoxatug Injection as part of their tetanus prophylaxis after injury. The study does not involve randomization or comparison groups but follows patients over time to monitor outcomes. A key part of the study is the follow-up at 90 days after administration to assess whether tetanus develops and to record any safety events. During the study, patient injury details and wound conditions will be carefully noted. Safety data will be selectively collected to identify any adverse reactions or serious events linked to Siltartoxatug use. The main outcome measure is the occurrence of tetanus within 90 days post-injection. Participants are followed for this 90-day period to evaluate treatment outcomes and safety.
CONDITIONS
Brief Title
A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Having received or will receive Siltartoxatug for tetanus prophylaxis following injury
- Provided signed informed consent by themselves or their legal representatives
You will not qualify if you...
- None
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single administration with observation up to 90 days
Participants receive Siltartoxatug Injection for tetanus prophylaxis following injury and their injury and wound conditions are documented.
1 baseline visit and follow-up visits up to 90 days
Duration - Up to 90 days post-treatment
Participants are followed up to determine clinical outcomes of tetanus prophylaxis and monitor for adverse reactions and serious adverse events after Siltartoxatug administration.
Approximately 1 to 2 follow-up visits within 90 days
Trial Site Locations
Total: 4 locations
1
The Second Affiliated Hospital of Shantou University
Shantou, Guangdong, China, 515041
Not Yet Recruiting
2
Xiangyun County People's Hospital
Xiangyun, Yunnan, China, 672100
Not Yet Recruiting
3
Shaoxing Central Hospital
Shaoxing, Zhejiang, China, 312030
Actively Recruiting
4
Zhoushan Putuo District People's Hospital
Zhoushan, Zhejiang, China, 316100
Not Yet Recruiting
Research Team
X
Xia Qu, Master
X
xinyu Liu, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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