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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Siltartoxatug Injection (Brand name: Sintetol®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siltartoxatug Injection (Brand name: Sintetol®) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome | Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate) | within 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome | Classification of wound characteristics in patients receiving Siltartoxatug Injection | within 90 days |
| Secondary Outcome | Incidence of adverse reactions and serious adverse events within 90 days post-administration of Siltartoxatug Injection |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving Siltartoxatug for tetanus prophylaxis following injury and providing informed consent for participation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Qu, Master | Contact | +86 0756 726399 | sammi.qu@trinomab.com | |
| xinyu Liu, Doctor | Contact | +86 0756 7263999 | liuxinyu@trinomab.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Shantou University | Not yet recruiting | Shantou | Guangdong | 515041 | China |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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|
| within 90 days |
| Xiangyun County People's Hospital | Not yet recruiting | Xiangyun | Yunnan | 672100 | China |
|
| Shaoxing Central Hospital | Recruiting | Shaoxing | Zhejiang | 312030 | China |
|
| Zhoushan Putuo District People's Hospital | Not yet recruiting | Zhoushan | Zhejiang | 316100 | China |
|
| D007239 | Infections |