Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin
Information source: Meir Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Penicillin Allergy
Intervention: Penicillin test and challenge (Drug)
Phase: Phase 4
Sponsored by: Meir Medical Center
Official(s) and/or principal investigator(s):
Arnon Goldberg, MD, Principal Investigator, Affiliation: Allergy and Clinical Immunology Unit, Meir Medical Center, Kfar Saba, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
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
Official title: Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: results of an oral challenge with penicillin (penicillin V) and amoxicillin
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
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.
Minimum age: 4 Years.
Maximum age: 90 Years.
Inclusion Criteria: patients with a history of non-life threatening allergic reaction to
penicillin, dating back at least 3 years -
Exclusion Criteria: Patients who had a life-threatening anaphylactic reaction to penicillin
consisting of unconsciousness or anaphylaxis requiring life-resuscitation and those who had
non-IgE mediated hypersensitivity reactions
Locations and Contacts
Meir Medical Center, Kfar Saba 44281, Israel
Starting date: January 1998
Ending date: May 2004
Last updated: August 10, 2006