Back to resultsPost Marketing Surveillance of Diphtheria Antitoxin (DAT)
Primary Purpose
Safety Issues
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Diphtheria Antitoxin
Sponsored by
About this trial
This is an interventional treatment trial for Safety Issues
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)
Sites / Locations
- RSUD Dr. Soetomo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational Product
Arm Description
Outcomes
Primary Outcome Measures
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
Precentage of serum sickness after administration of Diphtheria Antitoxin (DAT)
Secondary Outcome Measures
The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)
Precentage 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)
Precentage of positive reaction after sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
The occurrence of SAE after administration of Diphtheria Antitoxin (DAT)
Precentage of SAE after administration of Diphtheria Antitoxin (DAT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06053853
Brief Title
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
Official Title
Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
May 13, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Product
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Diphtheria Antitoxin
Intervention Description
Dosage form: Solution for injection
Dosage:
Perform sensitivity tests, and desensitization if necessary.
Give the entire treatment dose of antitoxin IV (or IM) in a single administration (except for series of injections needed for desensitization).
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
Primary Outcome Measure Information:
Title
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
Description
Precentage of serum sickness after administration of Diphtheria Antitoxin (DAT)
Time Frame
Within 10 days after injection
Secondary Outcome Measure Information:
Title
The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)
Description
Precentage of local and systemic reaction after administration of Diphtheria Antitoxin (DAT)
Time Frame
Within 24 hours to 10 days after injection
Title
The occurrence of positive reaction after a sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
Description
Precentage of positive reaction after sensitivity test (skin test) of Diphtheria Antitoxin (DAT)
Time Frame
Before injection of Diphtheria Antitoxin
Title
The occurrence of SAE after administration of Diphtheria Antitoxin (DAT)
Description
Precentage of SAE after administration of Diphtheria Antitoxin (DAT)
Time Frame
Within 10 days after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
RSUD Dr. Soetomo
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60286
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
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