Evaluation of the Efficacy and Safety of Tetanus Monoclonal Antibody in the Treatment of Patients with Severe Tetanus

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500111942

Enrollment

Unknown

Registered

2025-11-07

Start date

2025-11-15

Completion date

Unknown

Last updated

2025-11-11

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

Conditions

Tetanus

Interventions

Human Tetanus Immunoglobulin :Human Tetanus Immunoglobulin, 6000 IU, intramuscular multi-point injection, single administration.

20mg Sutezolidumab:Stedutumab Injection, 20mg, intramuscular injection, single administration

40mg Sutezolidumab:Stedutumab Injection, 40mg, intramuscular injection, single administration

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 80 years old. 2.Clinically diagnosed with severe tetanus (Ablett Grade III-IV). 3.Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.A history of severe allergy to monoclonal antibody drugs. 2.Complicated with other life-threatening infections or terminal diseases.

Design outcomes

Primary

Measure	Time frame
Number of convulsion attacks;Duration of convulsions;Degree of trismus;Autonomic Nervous System Dysfunction;	—

Secondary

Measure	Time frame
Dosage of sedative and analgesic drugs;ICU length of stay;Mechanical ventilation time;Serum TeNT neutralizing antibody titer (before treatment, 12 hours, 7 days, 28 days, 60 days after treatment),;hospitalization cost,;	—

Countries

China

Contacts

Public ContactWang Yongjie

Jilin Provincial People's Hospital

1479706712@qq.com+86 158 4308 1801

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026