MedTrace Logo

Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

NCT06053853 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-11-18

No results posted yet for this study

Summary

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

Conditions

  • Safety Issues

Interventions

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

Sponsors & Collaborators

  • PT Bio Farma

    lead INDUSTRY

Principal Investigators

  • Dominicus Husada, MD · Dr. Soetomo Hospital, Surabaya, Indonesia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-05-13
Completion
2023-05-23

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06053853 on ClinicalTrials.gov