Oral Penicillin Challenge and Allergy De-labeling in Children

Phase 4TerminatedNCT05563610

Phoenix Children's Hospital31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Penicillin Allergy

Interventions

Amoxicillin 500mgDRUG

Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies) 2. Patients at low risk of anaphylaxis as determined by the study questionnaire 3. 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. 4. Patients who are interested in participating 5. Patients who have an acceptable surrogate to give consent on the subject's behalf 6. Patients whose surrogate (parent/caregiver) speaks English or Spanish Exclusion Criteria: 1. Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate 2. Patients who have multiple drug allergies

Locations (1)

Phoenix Children's

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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