Tetanus
Conditions
Interventions
Experimental group:Stamulumab Injection 10mg
Control group:Human Tetanus Immunoglobulin 500 IU
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older (including 18), of any gender, and voluntarily sign the informed consent form. 2.Hospitalized patients classified as high risk for tetanus according to the "Non-neonatal Tetanus Diagnosis and Treatment Guidelines (2024 Edition)", with severe wound contamination or delayed presentation (exceeding 24 hours). (Note: High risk is defined as meeting any of the following criteria: failure to receive medical treatment within 6 hours; wound contamination with soil, human or animal feces, or mammalian saliva; puncture wounds; avulsion wounds; crush injuries; firearm injuries; burns; scalds; frostbite; presence of unremoved ischemic or necrotic tissue; unremoved foreign bodies in the wound; wounds with signs of infection, etc.); 3. Hospitalized patients with severe trauma: (AIS score >=3 or ISS >=16).
Exclusion criteria
Exclusion criteria: 1. Tetanus risk is classified as low; 2. Suspected or confirmed tetanus at the time of consultation; 3. History of confirmed tetanus infection; 4. Infectious fever with a temperature >38°C within 3 days prior to administration; (and non-infectious causes of fever have been ruled out); 5. Known to have received three or more doses of tetanus toxoid or a vaccine containing tetanus toxoid within the past 10 years; 6. History of severe drug, food or protein allergies; personal or immediate family history of bronchial asthma, hay fever, eczema or angioedema; 7. Congenital haemorrhagic disorders (e.g. haemophilia) or congenital platelet dysfunction; 8. History of epilepsy, convulsions or seizures, or a family history of psychiatric disorders; 9. Individuals with confirmed or suspected immunodeficiency or autoimmune diseases; those undergoing immunosuppressive therapy, such as having received anticancer chemotherapy or radiotherapy within the six months prior to the test, or long-term systemic corticosteroid treatment; 10. Use of live virus vaccines within the past 3 months, such as measles, mumps, polio or herpes vaccines; 11. Current alcohol abuse or substance abuse; 12. Known or suspected conditions deemed by the investigator to affect trial assessment, such as: severe respiratory disease, acute infection or active chronic disease, severe cardiovascular disease, liver or kidney disease, or malignant tumours; 13. Patients currently participating in other clinical trials; 14. Pregnant or breastfeeding women, or women planning to become pregnant during the study, and men planning to conceive; 15. Patients with a projected survival of less than 6 months; 16. Patients who have received passive immunisation within the last 3 months; 17. Subjects deemed unsuitable for participation in this study by the investigator due to other factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The increase in anti-tetanus neutralizing antibody titer from baseline at 12 hours post-dose.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tetanus protection rate within 90 days post-administration (at 7d/28d/90d), and the increase in anti-tetanus neutralizing antibody titer from baseline at other time points (7d/90d).;Efficacy Evaluation Criteria; | — |
Countries
China
Contacts
Public Contactwangzhihua
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed