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OpenTrials
Completed

NCT Number: NCT03404804

Oral Challenge in the Pediatric ED

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.

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

David Vyles

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Children with any basal condition (trauma, infection, minor accidents, etc..) will be able to participate in the study provided they and their family are willing and do not meet the above-mentioned exclusion criteria.

Treatment and study plan

Amoxicillin

Drug

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

Primary outcomes

  1. Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result

    Time frame: 1 and 7 day followup phone surveys were conducted.

    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.

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

    Time frame: 6 months and 12 months after oral challenge

    Conduct follow-up 6 months and 12 months after oral challenge for all children 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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Oral Penicillin Challenge in the Pediatric Emergency Department

Acronym: OPEN

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Jan 19, 2018
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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