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

Phase 4

Terminated

• Conditions: Penicillin Allergy

• Registration Number: NCT00363688
• Lead Sponsor: Meir Medical Center

Brief 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

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.

Study Timeline

• Status Verified: 1997-12
• Study Start: 1998-01
• Study Completion: 2004-05
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Last Update Submitted: 2006-08-10
• Study First Posted: 2006-08-15
• Last Update Posted: 2006-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
results of an oral challenge with penicillin (penicillin V) and amoxicillin

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel