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Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin

Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Penicillin Allergy

Intervention: Penicillin test and challenge (Drug)

Phase: Phase 4

Status: Terminated

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

Summary

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

Clinical Details

Official title: Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: results of an oral challenge with penicillin (penicillin V) and amoxicillin

Detailed description: 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.

Eligibility

Minimum age: 4 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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
Additional Information

Starting date: January 1998
Last updated: August 10, 2006

Page last updated: August 23, 2015

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