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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental | Diphtheria Antitoxin (DAT) Administered intravenously. Dosage:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria Antitoxin | Biological | Dosage form: Solution for injection Dosage:
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominicus Husada, MD | Dr. Soetomo Hospital, Surabaya, Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUD Dr. Soetomo | Surabaya | East Java | 60286 | Indonesia |
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| ID | Term |
|---|---|
| D004166 | Diphtheria Antitoxin |
| ID | Term |
|---|---|
| D000992 | Antitoxins |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |