Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

PT Bio Farma

Status and phase: Completed; Phase 4

Conditions: Safety Issues

Treatments: Biological: Diphtheria Antitoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06053853

DAT 0422

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Investigational Product

Experimental group

Description:

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

Treatment:

Biological: Diphtheria Antitoxin