At a glance
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Confirmatory Study to Examine Negative Predictive Value (NPV) and Safety of Skin Testing With PRE-PEN, a Minor Determinant MIxture (MDM) of Penicillin Antigens, and Amoxicillin Reagent Against an Oral Challenge With Amoxicillin
In Brief
A Phase 3 clinical trial evaluating Penicillin skin test kit for History of IgE Dependent Reaction to a Penicillin Product. Completed, enrolled 481 participants across 13 sites.
Detailed Summary
A self- or parent-reported history of penicillin allergy excludes approximately 10% of the US population from receiving penicillin (Kerr 1994, Kagy, Blaiss 1998, Solensky et al. 2000, Neugut et al. 2001). Yet approximately 80% of patients labeled as allergic to the penicillins can safely take these antibiotics without fear of a life-threatening reaction (Gadde et al. 1993, Macy et al. 1997). The outcomes of this erroneous classification of patients include unnecessary denial of an effective and well-tolerated class of antibiotics, which are often the treatment of choice. The primary aim of skin testing with the Penicillin Skin Test Kit is to identify subjects at very low risk of developing acute IgE-dependent reactions when given a penicillin or cross-reacting drug. The negative predictive value (NPV) of skin testing is assessed by oral challenge with a penicillin.
Study Details
Timeline
Interventions
Allergy skin testing is done by puncture and intradermal. If all tests negative, subjects receive an oral amoxicillin challenge.