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NCT Number: NCT07107932

A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

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.

Recruiting

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Key information

Conditions

Tetanus Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Shantou University, Shantou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Primary Outcome

    Time frame: within 90 days

    Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)

Secondary outcomes

  1. Secondary Outcome

    Time frame: within 90 days

    Classification of wound characteristics in patients receiving Siltartoxatug Injection

  2. Secondary Outcome

    Time frame: within 90 days

    Incidence of adverse reactions and serious adverse events within 90 days post-administration of Siltartoxatug Injection

Study contacts

Contact information is provided by the study sponsor or research team.

Xia Qu, Master

CONTACT

[email protected]

+86 0756 726399

xinyu Liu, Doctor

CONTACT

[email protected]

+86 0756 7263999

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 6, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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