A Registry: Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
1 other identifier
observational
10,000
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2025
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2025
CompletedStudy Start
First participant enrolled
July 31, 2025
CompletedFirst Posted
Study publicly available on registry
August 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2029
January 6, 2026
July 1, 2025
3.7 years
July 28, 2025
January 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome
Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)
within 90 days
Secondary Outcomes (2)
Secondary Outcome
within 90 days
Secondary Outcome
within 90 days
Study Arms (1)
Siltartoxatug Injection (Brand name: Sintetol®)
Interventions
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.
Eligibility Criteria
Patients receiving Siltartoxatug for tetanus prophylaxis following injury and providing informed consent for participation.
You may qualify if:
- Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;
- \. Provided signed informed consent by themselves or their legal representatives.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Second Affiliated Hospital of Shantou University
Shantou, Guangdong, 515041, China
Xiangyun County People's Hospital
Xiangyun, Yunnan, 672100, China
Shaoxing Central Hospital
Shaoxing, Zhejiang, 312030, China
Zhoushan Putuo District People's Hospital
Zhoushan, Zhejiang, 316100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 6, 2025
Study Start
July 31, 2025
Primary Completion (Estimated)
March 30, 2029
Study Completion (Estimated)
March 30, 2029
Last Updated
January 6, 2026
Record last verified: 2025-07