Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

Phase 4

Completed

• Conditions: Safety Issues
• Interventions: Biological: Diphtheria Antitoxin

• Registration Number: NCT06053853
• Lead Sponsor: PT Bio Farma

Brief 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.

Study Timeline

• Study Start: 2023-01-31
• Primary Completion: 2023-05-13
• Study Completion: 2023-05-23
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
• Subjects who received therapy with the intended DAT

Exclusion Criteria

• Receiving a different brand of Diphtheria Antitoxin (DAT)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Product	Diphtheria Antitoxin	Diphtheria Antitoxin (DAT) Administered intravenously. Dosage: * Mild diphtheria (nose, skin): 20,000 unit * Moderate diphtheria (tonsil - limited): 40,000 - 60,000 unit * Severe diphtheria (more than 1 tonsil, or to the pharyngeal wall, or more than 5 days of illness, or with bull neck): 80,000 - 120,000 unit

Primary Outcome Measures

Name	Time	Method
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)	Within 10 days after injection	Percentage of serum sickness after administration of Diphtheria Antitoxin (DAT)

Secondary Outcome Measures

Name	Time	Method
The occurrence of positive reaction after a sensitivity test (skin test) of Diphtheria Antitoxin (DAT)	Before injection of Diphtheria Antitoxin	Percentage of positive reaction after sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
The occurrence of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)	Within 10 days after injection	Percentage of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)
The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)	Within 24 hours to 10 days after injection	Percentage of local and systemic reaction after administration of Diphtheria Antitoxin (DAT)

Trial Locations

Locations (1)

RSUD Dr. Soetomo; 🇮🇩 Surabaya, East Java, Indonesia