drugset / Trial / NCT01818336

Evaluation of Skin Testing Reagents for Penicillin Allergy

NCT01818336

Phase 3 Completed 481 enrolled AllerQuest LLC
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2012-12
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified Other
Subject Amoxicillin Other / unclassified Oral
Subject Benzylpenicillin Unknown Other
Subject MDM (minor determinant mixture of penicillins) Unknown Other
Subject PRE-PEN Unknown Other