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Research on the Method of Real World Data Supporting Drug Vigilance in Children's Medication: Safety Evaluation of Agkistrodon acutus Hemocoagulase and Azithromycin after Marketing in Children's Population

Research on the Method of Real World Data Supporting Drug Vigilance in Children's Medication: Safety Evaluation of Agkistrodon acutus Hemocoagulase and Azithromycin after Marketing in Children's Population

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500104309
Enrollment
Unknown
Registered
2025-06-15
Start date
2024-10-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

None

Interventions

Agkistrodon acutus thrombin group:None
Azithromycin group:None

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inpatients in Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology from January 1, 2021 to March 31, 2024; 2. Patient age less than 18 years; 3. The patient has used rheucolaticase or azithromycin (neither drug is limited to the dosage form).

Exclusion criteria

Exclusion criteria: 1.Patient aged 18 years or older

Design outcomes

Primary

MeasureTime frame
Adverse reaction incidence rate;—

Secondary

MeasureTime frame
Related factors affecting the occurrence of adverse reactions;—

Countries

China

Contacts

Public ContactYou Ruxu

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

youruxu2008@163.com+86 27 85726077

Outcome results

None listed

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