Oral Penicillin Challenge and Allergy De-labeling in Children

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

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 Overview

• Status: Terminated
• Conditions: Penicillin Allergy
• Intervention / Treatment: Drug: Amoxicillin 500mg

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Challenge; 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; Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not; Other Names: Oral Challenge
No Intervention: No Oral Challenge; 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

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital
• Investigators: Principal Investigator: Diane E Hindman, MD PharmD, Emergency Department Attending Physician

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; emergency department; allergy; amoxicillin; penicillin; anaphylaxis; oral challenge
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: IRB-22-154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD with other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No