Penicillin De-labeling in the Pediatric Primary Care Setting

Study Overview
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Brief Summary
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While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling strategy. However, there is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the United States, and implementing outpatient primary care-based delabeling strategies in low-risk patients may increase access to delabeling assessments. However, a recent survey of pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care. Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. With this, the primary aim of this study is to evaluate the number of patients for which risk-stratification and direct amoxicillin challenge are successfully completed in an outpatient pediatric primary care clinic.

Official Title
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Penicillin De-labeling in the Pediatric Primary Care Setting

Conditions
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Penicillin Allergy, Penicillin Reaction

Intervention / Treatment
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* Drug: Amoxicillin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from ages 2-18 years with a history of parent-reported penicillin allergy. Exclusion Criteria: Children with a history of reaction consistent with a severe cutaneous adverse reaction to penicillin as defined as a history of oral blisters, diffuse skin peeling or blisters after taking a penicillin, or having the diagnosis of Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug rash with eosinophilia and systemic symptoms will be excluded. Pregnant and breastfeeding female subjects will be excluded

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric Patients with a history of penicillin allergy<br> | Drug: Amoxicillin<br>* Two-dose amoxicillin challenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects who complete risk-stratification of penicillin allergy in the pediatric primary care setting |  | Day 1 | 
| Subjects stratified as low-risk with a negative immediate amoxicillin challenge in the pediatric primary care setting |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penicillin allergy labeling in subjects with negative amoxicillin challenge | Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge. | 10-14 months after amoxicillin challenge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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penicillin, allergy