Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

NCT06053853 | Completed Phase 4 DMC

• 1 other identifier: DAT 0422
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The occurrence of local and systemic reactions 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)

  Before injection of Diphtheria Antitoxin

• The occurrence of serious adverse event (SAE) after administration of Diphtheria Antitoxin (DAT)

  Within 10 days after injection

Study Arms (1)

Investigational Product

EXPERIMENTAL

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

Interventions

Diphtheria Antitoxin BIOLOGICAL

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

Investigational Product

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a probable diagnosis or laboratory confirmation of Diphtheria.
• Subjects who received therapy with the intended DAT

You may not qualify if:

• Receiving a different brand of Diphtheria Antitoxin (DAT)

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (1)

RSUD Dr. Soetomo

Surabaya, East Java, 60286, Indonesia

Location

MeSH Terms

Interventions

Diphtheria Antitoxin

Intervention Hierarchy (Ancestors)

Antitoxins; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Officials

• Dominicus Husada, MD

  Dr. Soetomo Hospital, Surabaya, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: September 26, 2023
• Study Start: January 31, 2023
• Primary Completion: May 13, 2023
• Study Completion: May 23, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

ID (1)