Status:
COMPLETED
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
Lead Sponsor:
PT Bio Farma
Conditions:
Safety Issues
Eligibility:
All Genders
1-70 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
- Subjects who received therapy with the intended DAT
Exclusion
- Receiving a different brand of Diphtheria Antitoxin (DAT)
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2023
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06053853
Start Date
January 31 2023
End Date
May 23 2023
Last Update
November 18 2023
Active Locations (1)
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1
RSUD Dr. Soetomo
Surabaya, East Java, Indonesia, 60286