Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin
Primary Purpose
Penicillin Allergy
Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Penicillin test and challenge
Sponsored by
About this trial
This is an interventional diagnostic trial for Penicillin Allergy focused on measuring Non life threatening allergic reaction, oral challenge, penicillin, skin testing
Eligibility 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 -
Sites / Locations
- Meir Medical Center
Outcomes
Primary Outcome Measures
results of an oral challenge with penicillin (penicillin V) and amoxicillin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00363688
Brief Title
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin
Official Title
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?
Study Type
Interventional
2. Study Status
Record Verification Date
December 1997
Overall Recruitment Status
Terminated
Study Start Date
January 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Meir Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy
Keywords
Non life threatening allergic reaction, oral challenge, penicillin, skin testing
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Penicillin test and challenge
Primary Outcome Measure Information:
Title
results of an oral challenge with penicillin (penicillin V) and amoxicillin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
90 Years
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Goldberg, MD
Organizational Affiliation
Allergy and Clinical Immunology Unit, Meir Medical Center, Kfar Saba, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
12. IPD Sharing Statement
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Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin
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