Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin
NCT ID: NCT00363688
Last Updated: 2006-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
INTERVENTIONAL
1998-01-31
2004-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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Penicillin test and challenge
Eligibility Criteria
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Exclusion Criteria
4 Years
90 Years
ALL
No
Sponsors
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Meir Medical Center
OTHER
Principal Investigators
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Arnon Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
Allergy and Clinical Immunology Unit, Meir Medical Center, Kfar Saba, and Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Locations
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Meir Medical Center
Kfar Saba, , Israel
Countries
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Other Identifiers
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756497
Identifier Type: -
Identifier Source: org_study_id