Diphtheria Antitoxin

Defining DAT eligibility

Patients who meet the case definition for suspect or confirmed respiratory diphtheria are eligible to receive DAT.

DAT may also be used in cases of respiratory diphtheria-like illness caused by laboratory-confirmed toxigenic Corynebacterium ulcerans.

DAT use is a clinical decision

FDA regulation of treatments given under EA-IND protocols mandate that only a patient's treating physician can request and administer DAT.

The treating physician

• Makes the final decision on DAT use
• May revise the diagnosis
• Can decide against administering DAT after it's released

If DAT is administered, the treating physician becomes a co-investigator in the DAT EA-IND. The treating physician must also provide reports to CDC following the patient's treatment.

Requesting DAT

A U.S. physician caring for an eligible patient should first consult with their state health department.

The treating physician can then obtain DAT by

1. Contacting CDC's Emergency Operations Center (770-488-7100)
2. Deciding that DAT is indicated
3. Discussing the DAT release protocol with a CDC diphtheria duty officer

Once a treating physician determines that it is indicated, CDC dispatches DAT from one of the U.S. Quarantine Stations.

Returning unused DAT

If the antitoxin isn't given for any reason after it's released by CDC, then it should be returned. Ship it in a cold pack by overnight mail to:

CDC Drug Service (Mailstop H23-6)
Centers for Disease Control and Prevention
1600 Clifton Road, Atlanta Georgia 30329
Phone: (404) 639-3670

DAT forms and worksheets

Download a zip file [3.6 MB] with all the following documents or access each individually below:

• Cover letter to clinicians for DAT release
• Protocol: Use of DAT for suspected diphtheria cases
• Guide to skin testing for sensitivity to DAT

Note: Zip file doesn't contain Appendix 5. Please download directly from the FDA website.

Appendices

• Appendix 1: Informed consent/parent permission for use of DAT
• Appendix 2: Close contact form
• Appendix 3: Diphtheria worksheet
• Appendix 4: DAT treatment and adverse effects form
• Appendix 5: Investigator statement form—FDA 1572
• Appendix 6: DAT product accountability and disposition form
• Appendix 7: CDC IRB memo
• Appendix 8: Certificate of confidentiality

Resources

Key questions to consider when assessing suspected respiratory diphtheria

Test directory: Submitting specimens to CDC