Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

November 16, 2023 updated by: PT Bio Farma

Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60286
        • RSUD Dr. Soetomo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Product

Diphtheria Antitoxin (DAT)

Administered intravenously.

Dosage:

  • Mild diphtheria (nose, skin): 20,000 unit
  • Moderate diphtheria (tonsil - limited): 40,000 - 60,000 unit
  • Severe diphtheria (more than 1 tonsil, or to the pharyngeal wall, or more than 5 days of illness, or with bull neck): 80,000 - 120,000 unit
Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of serum sickness after administration of Diphtheria Antitoxin (DAT)
Time Frame: Within 10 days after injection
Percentage of serum sickness after administration of Diphtheria Antitoxin (DAT)
Within 10 days after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of local and systemic reactions after administration of Diphtheria Antitoxin (DAT)
Time Frame: Within 24 hours to 10 days after injection
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)
Time Frame: Before injection of Diphtheria Antitoxin
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)
Time Frame: Within 10 days after injection
Percentage of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)
Within 10 days after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT Bio Farma

Investigators

  • Principal Investigator: Dominicus Husada, MD, Dr. Soetomo Hospital, Surabaya, Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Actual)

May 13, 2023

Study Completion (Actual)

May 23, 2023

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAT 0422

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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