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NCT00363688 Clinical Trial

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

Penicillin Allergy Clinical Trial

Official title:
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin: Is It Safe?

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00363688
Other study ID # 756497
Secondary ID
Status Terminated
Phase Phase 4
First received August 10, 2006
Last updated August 10, 2006
Start date January 1998
Est. completion date May 2004

Study information
Verified date December 1997
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date May 2004
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 4 Years to 90 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Penicillin test and challenge

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary results of an oral challenge with penicillin (penicillin V) and amoxicillin
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