Penicillin Allergy Clinical Trial
Official title:
Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique
The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.
The primary objective of the study is to evaluate the equivalency of the skin test
reactivity to penicilloate prepared by our new method of penicilloate preparation versus our
old method of penicilloate preparation. The secondary objective of the study is to evaluate
the significance of the different diastereoisomers of penicilloate on skin test reactivity.
Five (5) adult subjects without a history of penicillin allergy and fifteen (15) adult
subjects with a history of penicillin allergy and previous positive penicillin skin test to
the minor determinant (penicilloate) and/or major determinant (penicilloyl) will be enrolled
into the study. Each subject will be skin tested with our current penicillin skin test which
includes penicilloate conducted in the Division of Allergic Diseases will be compared the
skin test of our penicilloate prepared by our newer method along with the different
diastereoisomers of penicilloic acid on the same day and time. The adult subjects without a
history of penicillin allergy will serve as our control.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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