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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00363688
Enrollment
Unknown
Registered
2006-08-15
Start date
1998-01-31
Completion date
2004-05-31
Last updated
2006-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penicillin Allergy

Keywords

Non life threatening allergic reaction, oral challenge, penicillin, skin testing

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.

Interventions

DRUGPenicillin test and challenge

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 90 Years

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 \-

Design outcomes

Primary

MeasureTime frame
results of an oral challenge with penicillin (penicillin V) and amoxicillin

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026