Clinical trial
Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia
Name
DAT 0422
Description
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
Trial arms
Trial start
2023-01-31
Estimated PCD
2023-05-13
Trial end
2023-05-23
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Investigational Product
Size
68
Primary endpoint
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
Within 10 days after injection
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 68, 'type': 'ACTUAL'}}
Updated at
2023-11-18
1 organization
1 product
1 indication
Product
Diphtheria AntitoxinIndication
Safety IssuesOrganization
PT Bio Farma