Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

Safety Issues Clinical Trial

Official title:

Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06053853
• Other study ID #: DAT 0422
• Status: Completed
• Phase: Phase 4
• Start date: January 31, 2023
• Est. completion date: May 23, 2023

Study information

• Verified date: November 2023
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 23, 2023
• Est. primary completion date: May 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diphtheria
• Safety Issues

Intervention

Biological:
• Diphtheria Antitoxin
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

Locations

Country	Name	City	State
Indonesia	RSUD Dr. Soetomo	Surabaya	East Java

Sponsors (1)

Lead Sponsor	Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	The occurrence of positive reaction after a sensitivity test (skin test) of Diphtheria Antitoxin (DAT)	Percentage of positive reaction after sensitivity test (skin test) of Diphtheria Antitoxin (DAT)	Before injection of Diphtheria Antitoxin
Secondary	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