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

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ClinicalTrials.gov Identifier: NCT00363688
Recruitment Status : Terminated
First Posted : August 15, 2006
Last Update Posted : August 15, 2006
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Penicillin Allergy Drug: Penicillin test and challenge Phase 4

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 Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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?
Study Start Date : January 1998
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Penicillins




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


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00363688     History of Changes
Other Study ID Numbers: 756497
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: August 15, 2006
Last Verified: December 1997

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

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents