Health TrialsbyHealthPanel

A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury

ConditionTetanus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorZhuhai Trinomab Pharmaceutical Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;

2. Provided signed informed consent by themselves or their legal representatives.

Disqualifiers

None

Trial population

Patients receiving Siltartoxatug for tetanus prophylaxis following injury and providing informed consent for participation.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: Siltartoxatug Injection (Brand name: Sintetol®)1 intervention

Trial outcomes

Primary outcomes

1

Primary Outcome

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

Time frame
within 90 days

Secondary outcomes

1

Secondary Outcome

Classification of wound characteristics in patients receiving Siltartoxatug Injection

Time frame
within 90 days
2

Secondary Outcome

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

Time frame
within 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now