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Recruiting NCT07107932

A Registry: Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

Observational Tetanus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Siltartoxatug Injection (Brand name: Sintetol®).
Who it may be relevant to
Registry conditions: Tetanus. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

Overview

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.

Interventions

  • Drug Siltartoxatug Injection (Brand name: Sintetol®)
    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.

Primary outcome measures

  • Primary Outcome [Time frame: within 90 days]
Secondary outcome measures (2)
  • Secondary Outcome [Time frame: within 90 days]
  • Secondary Outcome [Time frame: within 90 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 4 centers
  • The Second Affiliated Hospital of Shantou University — Shantou
  • Xiangyun County People's Hospital — Xiangyun
  • Shaoxing Central Hospital — Shaoxing
  • Zhoushan Putuo District People's Hospital — Zhoushan

Identifiers

NCT: NCT07107932 · TNM002-402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗