Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

PT Bio Farma68 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Safety Issues

Interventions

Diphtheria AntitoxinBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 70 Years

Medical Language ↔ Plain English

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)

Locations (1)

RSUD Dr. Soetomo

Surabaya, East Java, Indonesia

Outcomes

Primary Outcomes

The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)

Percentage of serum sickness after administration of Diphtheria Antitoxin (DAT)

Time frame: Within 10 days after injection

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

Time frame: Within 10 days after injection

Data from ClinicalTrials.gov

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