Oral Challenge in the Pediatric ED

NCT ID: NCT03404804

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2022-12-04

Brief Summary

Our primary objective was to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge in the PED to test for an IgE-mediated allergic reaction. This was a 3-site pediatric emergency department study in which we challenged patients who met specific inclusion and exclusion criteria and were deemed low-risk.

Original aims included:

Aim 1: Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit.

Aim 2: Conduct follow-up one day after oral challenge for all children and seven days after oral challenge for patients discharged with a prescription antibiotic to determine if a delayed or T-Cell mediated reaction occurs after exposure to multiple doses of penicillin or any other antibiotic prescribed at discharge.

Aim 3: Examine health care outcomes and prescription-related costs associated with illness treatment plans in children who are de-labeled as penicillin allergic after an oral challenge.

A secondary objective within the IRB protocol reports, "Our secondary objective is to examine whether health care outcomes and prescription-related costs are comparable between children who are de-labeled as penicillin allergic after an oral challenge compared to a standard of care group who are not challenged in the PED."

However, we never proceeded with enrolling patients with PCN allergy not challenged in the PED as it was planned for later in the study that did not come to fruition.

Detailed Description

A convenience sample of children aged 2 to 16 years who presented to the pediatric emergency department with a reported PCN allergy were administered an allergy questionnaire to determine risk-level designation. Low-risk eligible patients were offered an oral amoxicillin challenge. Differences among sites for family and provider interest in participation with oral challenges were analyzed.

Conditions

Penicillin Allergy; Pediatric Emergency Medicine

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Oral Challenge

Patients with low-risk symptoms of amoxicillin allergy who receive oral amoxicillin to delabel their respective allergy.

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy

Interventions

Amoxicillin

Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children aged 2-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit.
• Only children well enough to be discharged to home at the conclusion of the PED visit are eligible.

Exclusion Criteria

• Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).
• Any contraindication to allergy testing will also result in exclusion
• (i.e. history of a severe allergic reaction to skin tests,,
• anaphylaxis in the past six weeks,
• known pregnancy
• child has a history of a condition that requires a beta blocker medicine for cardiac conditions, high blood pressure, migraine headaches, or eye drops for glaucoma (e.g. propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops).
• Children who present to the PED with a rash, vomiting or current asthma symptoms including coughing, wheezing or breathing problems will also be excluded to ensure these do not mask reactions to an oral challenge.
• Patients deemed too acutely ill for participation (triage level 1 or 2 or as determined by the ED patient care team) will be excluded from the study.
• During this pilot study, we will exclude non-English speaking families. However, in subsequent studies we will include the non-English speaking population.
• Children who are wards of the state, in foster care or police custody or detention will be excluded.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

David Edward Vyles

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David E Vyles, DO, MS

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

David Vyles

Milwaukee, Wisconsin, United States

Countries

United States

References

Vyles D, Chiu A, Routes J, Castells M, Phillips EJ, Visotcky A, Fraser R, Pezzin L, Brousseau DC. Oral amoxicillin challenges in low-risk children during a pediatric emergency department visit. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1126-1128.e1. doi: 10.1016/j.jaip.2019.09.022. Epub 2019 Oct 3. No abstract available.

Reference Type: DERIVED

PMID: 31586667 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1069530-3

Identifier Type: -

Identifier Source: org_study_id