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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 ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø's Emergency Operations Center (770-488-7100)
2. Deciding that DAT is indicated
3. Discussing the DAT release protocol with a ÐÇ¿ÕÓéÀÖ¹ÙÍø diphtheria duty officer

Once a treating physician determines that it is indicated, ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 ÐÇ¿ÕÓéÀÖ¹ÙÍø, then it should be returned. Ship it in a cold pack by overnight mail to:

ÐÇ¿ÕÓéÀÖ¹ÙÍø 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 .

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:
• Appendix 6: DAT product accountability and disposition form
• Appendix 7: ÐÇ¿ÕÓéÀÖ¹ÙÍø IRB memo
• Appendix 8: Certificate of confidentiality

Resources

Key questions to consider when assessing suspected respiratory diphtheria

Test directory: Submitting specimens to ÐÇ¿ÕÓéÀÖ¹ÙÍø