Oral Penicillin Challenge and Allergy De-labeling in Children

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. The secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the Pediatric Emergency Department.

Official Title
-----------------
Oral Penicillin Challenge and Allergy De-labeling in the Phoenix Children's Hospital Emergency Department

Conditions
-----------------
Penicillin Allergy

Intervention / Treatment
-----------------
* Drug: Amoxicillin 500mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies) Patients at low risk of anaphylaxis as determined by the study questionnaire Patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, Group A Streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for Helicobacter pylori eradication, or other acute infections deemed susceptible. Patients who are interested in participating Patients who have an acceptable surrogate to give consent on the subject's behalf Patients whose surrogate (parent/caregiver) speaks English or Spanish Exclusion Criteria: Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate Patients who have multiple drug allergies

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Challenge<br>Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge. | Drug: Amoxicillin 500mg<br>* Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not<br>* Other names: Oral Challenge;|
| No Intervention: No Oral Challenge<br>Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to no oral amoxicillin 500 mg challenge.. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| True Penicillin Allergies | Percentage of study patients presenting to the pediatric ED who received the amoxicillin oral challenge who demonstrated a true IgE-mediated allergic reaction | 24 hours after amoxicillin oral challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amoxicillin Oral Challenge Safety - High-Risk Reactions | Percentage of high-risk penicillin allergic reactions | 24 hours after amoxicillin oral challenge | 
| Amoxicillin Oral Challenge Safety - Admissions | Percentage of admissions from the pediatric ED in patients experiencing high-risk penicillin allergic reactions | 24 hours after amoxicillin oral challenge | 
| Amoxicillin Oral Challenge Safety - Re-admissions | Percentage of re-admissions from home after discharge from the pediatric ED in patients experiencing high-risk penicillin allergic reactions | 24 hours after amoxicillin oral challenge | 
| Amoxicillin Oral Challenge Safety - Deaths | Percentage of deaths in patients experiencing high-risk penicillin allergic reactions | 24 hours after amoxicillin oral challenge | 
| Amoxicillin Oral Challenge Feasibility | Average hospital length of stay in the pediatric ED for patients receiving the amoxicillin oral challenge relative to the non-treatment group | 24 hours after amoxicillin oral challenge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
penicillin, anaphylaxis, allergy, oral challenge, amoxicillin, pediatric, emergency department