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Evaluation of the efficacy and safety of stetustata monoclonal antibody in patients with confirmed tetanus infection: A multicenter, prospective, open-label clinical study

Evaluation of the efficacy and safety of stetustata monoclonal antibody in patients with confirmed tetanus infection: A multicenter, prospective, open-label clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125946
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tetanus

Interventions

A:After the diagnosis of tetanus, the Stetudata monoclonal antibody was directly used in combination with standard treatment (debridement, antibiotics,
B:For patients who did not receive referrals from lower-level hospitals, those who had received conventional passive immunization (such as HTIG or TAT)

Sponsors

Wuhan University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients (aged 18 years or above) with confirmed tetanus infection; 2. After excluding other causes, meet at least one of the following criteria: Typical clinical manifestations (grimacing, grimacing expression, muscle rigidity/spasm) (regardless of whether there is a history of trauma); Cultures from wound specimens detect Clostridium tetani; 3. Patients consent to participate in this study and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Combine with other severe neurological disorders (such as encephalitis, spinal cord injury); 2. This trauma has caused irreversible brain damage (GCS remains = 5 points continuously); 3. Planned to participate in other clinical trials during the study period, but assessed by the investigator as not suitable for participation; 4. Terminal illness (expected lifespan < 3 months); 5. Pregnant, lactating women or women who plan to get pregnant during the study period, and men; 6. The investigator believes that the subject has any condition that may interfere with the assessment of the study purpose; 7. Known to be allergic to the components of the monoclonal antibody; 8. Unable to obtain informed consent from the subject or their legal representative.

Design outcomes

Primary

MeasureTime frame
Ablett;

Secondary

MeasureTime frame
Titer level of anti-tetanus neutralizing antibodies;Muscle strength and muscle tone;Evaluation of Autonomic Nervous System Dysfunction;Assessment of Daily Living Skills;

Countries

China

Contacts

Public ContactLiwen

Wuhan University People's Hospital

595790125@qq.com+86 158 7135 8933

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026