NCT06053853

Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: PT Bio Farma · Industry
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin

Detailed description

To assess the occurrence of serum sickness after Diphtheria Antitoxin administration. To assess local and systemic reactions within 24 hours to 10 days. To assess the occurrence of positive reactions after the sensitivity test (skin test). To assess the presence of SAE after Diphtheria Antitoxin administration.

Conditions

• Safety Issues

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria Antitoxin	Dosage form: Solution for injection Dosage: 1. Perform sensitivity tests, and desensitization if necessary. 2. Give the entire treatment dose of antitoxin IV (or IM) in a single administration (except for series of injections needed for desensitization). 3. The recommended DAT treatment dosage ranges (pediatric and adult) are: * Pharyngeal or laryngeal disease of 2 days duration 20,000 - 40,000 unit * Nasopharyngeal disease 40,000 - 60,000 unit * Extensive disease of 3 or more days duration, or any patient with diffuse swelling of neck 80,000 - 100,000 unit * Skin lesions only (rare case where treatment is indicated) 20,000 - 40,000 unit

Timeline

• Start date: 2023-01-31
• Primary completion: 2023-05-13
• Completion: 2023-05-23
• First posted: 2023-09-26
• Last updated: 2023-11-18

Locations

1 site across 1 country: Indonesia