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OpenTrials
Completed

NCT Number: NCT06053853

Post Marketing Surveillance of Diphtheria Antitoxin (DAT)

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

Completed

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Key information

Conditions

Safety Issues

Age range

1 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RSUD Dr. Soetomo

Surabaya, East Java, 60286, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diphtheria Antitoxin

Biological

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

PT Bio Farma

Industry

Registry information

Official study title

Safety Profile of Diphtheria Antitoxin (DAT) in Indonesia

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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