Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
NCT ID: NCT06053853
Last Updated: 2023-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2023-01-31
2023-05-23
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Investigational Product
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Subjects who received therapy with the intended DAT
Exclusion Criteria
1 Year
70 Years
ALL
No
Sponsors
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PT Bio Farma
INDUSTRY
Responsible Party
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Principal Investigators
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Dominicus Husada, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. Soetomo Hospital, Surabaya, Indonesia
Locations
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RSUD Dr. Soetomo
Surabaya, East Java, Indonesia
Countries
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Other Identifiers
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DAT 0422
Identifier Type: -
Identifier Source: org_study_id
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