Penicillin Allergy Clinical Trial
Official title:
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?
The purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results
Objective: To examine whether oral challenge with penicillin for patients with a known
history of non-life threatening allergic reaction to penicillin is well-tolerated
irrespective of skin-testing results long after the event occurred.
Methods: In this prospective, open-label, controlled, multi-clinical trial, 8702 individuals
from primary care clinics were screened for penicillin allergy. 169 patients with a history
of non-life threatening allergic reaction to penicillin, dating back at least 3 years, were
recruited for study. Regardless of the response to penicillin skin testing, patients
received the recommended daily dosage of penicillin and amoxicillin on two separate
occasions. 2-6 years later a follow-up was conducted to assess the outcomes of further
penicillin administration.
Results: 92.9% of the patients had an allergic reaction 6 years or longer before enrollment
in the study. Of 272 challenges, 137 were skin-test positive with mild rash in 9 patients
(6.6%), and 135 were skin-test negative with similar allergic reaction in 5 (3.7%) (P =.29).
At follow-up, 3 of 55 patients (5.5%) who were given a full treatment course of penicillin
developed mild skin eruption.
Conclusions: A positive penicillin skin testing of patients with a history of non-life
threatening allergic reaction to penicillin occurring 3 years or longer from the event was
not associated with a greater prevalence of adverse reactions to oral challenge with
penicillin than a negative one. It is of importance to determine whether oral challenge can
serve as a diagnostic procedure for this particular group of patients, thereby saving the
need for prior penicillin skin testing.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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