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BB-IND 11184 Diphtheria Antitoxin (DAT) Protocol CDC IRB #4167 Version 7.0
Page 5 September 21, 2016
5.0 ELIGIBILITY
5.1 Therapeutic Use
Patients who have probable or confirmed respiratory diphtheria are eligible to receive DAT. The Council
of State and Territorial Epidemiologists approved of the following clinical case definition for respiratory
diphtheria: an upper respiratory tract illness characterized by sore throat, a low grade fever, and an
adherent membrane of the tonsil(s), pharynx, larynx, and/or nose.
Laboratory criteria for diagnosis: Isolation of Corynebacterium diphtheriae from a clinical specimen or
histopathologic diagnosis of diphtheria.
Case classification: For reporting purposes, cases are classified as probable or confirmed:
Probable: a clinically compatible case that is not laboratory confirmed and is not
epidemiologically linked to a laboratory-confirmed case
Confirmed: a clinically compatible case that is either laboratory confirmed or epidemiologically
linked to a laboratory-confirmed case
A patient’s eligibility for treatment will be determined through discussion between the CDC diphtheria
duty officer and the treating physician.
DAT should be released and administered without delay to:
A. All cases of respiratory diphtheria with laboratory-confirmed toxigenic Corynebacterium
diphtheriae or diphtheria-like cases with laboratory-confirmed toxigenic Corynebacterium
ulcerans.
B. Probable cases. Diphtheria should be strongly suspected in a probable case-patient who is toxic in
appearance and one or more of the following:
is without another clearly established diagnosis
has rapidly worsening illness
has history of recent travel to a country where diphtheria is endemic or epidemic
was exposed to travelers from countries with endemic or epidemic diphtheria
has history of recent contact with dairy animals,
was never vaccinated or is not up-to-date with diphtheria toxoid vaccination
For probable cases which are considered to have a low probability for diphtheria, the duty officer
will encourage the treating physician to consider other diagnoses. However the final decision to
request and administer DAT to a patient lies with the treating physician.
C. Case-patients who have isolated or localized lesions in the nose, eye, skin, or other anatomical
sites from which C. diphtheriae is obtained, and in whom there are signs of systemic toxicity
(fever, tachycardia (myocarditis), and weakness (neuropathy)). Otherwise, DAT treatment is not
routinely indicated for treatment of cutaneous diphtheria skin infection; toxigenic sequelae are
rare when the infection is limited to the skin and when the case-patient is up-to-date on
vaccination with diphtheria toxoid.
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