Oral Challenge in the Pediatric ED

NCT03404804 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1069530-3
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Penicillin Allergy; Pediatric Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result

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

  1 and 7 day followup phone surveys were conducted.

Secondary Outcomes (1)

• Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure

  6 months and 12 months after oral challenge

Study Arms (1)

Oral Challenge

EXPERIMENTAL

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

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

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

Oral Challenge

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal).
• (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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

David Vyles

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 31586667 DERIVED

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David Vyles, DO
• Organization: Medical College of Wisconsin

dvyles@mcw.edu

414-266-2625

Study Officials

• David E Vyles, DO, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: December 4, 2017
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2022
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)