Siltartoxatug injection to prevent tetanus after injury
A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
This registry will follow people who receive Siltartoxatug after an injury to see if it prevents tetanus and to record any side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | Zhuhai Trinomab Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 4 sites (Shantou, Guangdong and 3 other locations) |
| Trial ID | NCT07107932 on ClinicalTrials.gov |
What this trial studies
This is an observational registry that documents the injury and wound characteristics of patients who receive Siltartoxatug for tetanus prophylaxis. Enrolled participants will be followed for 90 days after administration to determine whether tetanus occurs. The registry will collect selective safety data, including adverse reactions and serious adverse events, after Siltartoxatug administration. Data are being collected at multiple hospital sites in China without altering standard clinical care.
Who should consider this trial
Good fit: People who have sustained an injury and have received or will receive Siltartoxatug for tetanus prophylaxis and can provide informed consent (or have a legal representative who can) are eligible.
Not a fit: Patients who do not receive Siltartoxatug, who already have clinical tetanus at enrollment, or who cannot be followed for the 90-day period are unlikely to gain preventive or outcome information from this registry.
Why it matters
Potential benefit: If successful, the registry could confirm that Siltartoxatug reduces the risk of tetanus after injury and provide real-world safety information to guide its use.
How similar studies have performed: Passive immunotherapy for tetanus using human tetanus immunoglobulin is an established approach, but Siltartoxatug is a newer agent with limited published real-world data, so this registry aims to collect additional outcomes and safety information.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury; * 2\. Provided signed informed consent by themselves or their legal representatives. Exclusion Criteria: * None
Where this trial is running
Shantou, Guangdong and 3 other locations
- The Second Affiliated Hospital of Shantou University — Shantou, Guangdong, China (Not_yet_recruiting)
- Xiangyun County People's Hospital — Xiangyun, Yunnan, China (Not_yet_recruiting)
- Shaoxing Central Hospital — Shaoxing, Zhejiang, China (Recruiting)
- Zhoushan Putuo District People's Hospital — Zhoushan, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: Xia Qu, Master
- Email: sammi.qu@trinomab.com
- Phone: +86 0756 726399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.