Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

PHASE4CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

January 31, 2023

Primary Completion Date

May 13, 2023

Study Completion Date

May 23, 2023

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"

Trial Locations (1)

60286

RSUD Dr. Soetomo, Surabaya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PT Bio Farma

INDUSTRY