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

This study has been terminated.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00363688
First received: August 10, 2006
Last updated: NA
Last verified: December 1997
History: No changes posted
  Purpose

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


Condition Intervention Phase
Penicillin Allergy
Drug: Penicillin test and challenge
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • results of an oral challenge with penicillin (penicillin V) and amoxicillin

Study Start Date: January 1998
Estimated Study Completion Date: May 2004
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

Ages Eligible for Study:   4 Years to 90 Years
Genders Eligible for Study:   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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363688

Locations
Israel
Meir Medical Center
Kfar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Arnon Goldberg, MD Allergy and Clinical Immunology Unit, Meir Medical Center, Kfar Saba, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00363688     History of Changes
Other Study ID Numbers: 756497
Study First Received: August 10, 2006
Last Updated: August 10, 2006
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
Non life threatening allergic reaction
oral challenge
penicillin
skin testing

Additional relevant MeSH terms:
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014