Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

Study Overview
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Brief Summary
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The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin

Detailed Description
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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.

Official Title
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Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia

Conditions
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Safety Issues

Intervention / Treatment
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* Biological: Diphtheria Antitoxin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Product<br>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 | Biological: Diphtheria Antitoxin<br>* Dosage form: Solution for injection Dosage: Perform sensitivity tests, and desensitization if necessary. Give the entire treatment dose of antitoxin IV (or IM) in a single administration (except for series of injections needed for desensitization). 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT) | Percentage of serum sickness after administration of Diphtheria Antitoxin (DAT) | Within 10 days after injection | 

Secondary Outcome Measures

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