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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014