Safety Issues
Conditions
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.
Interventions
BIOLOGICALDiphtheria 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
Sponsors
PT Bio Farma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Indonesia
Outcome results
None listed