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Oral Challenge in the Pediatric ED (OPEN)

Primary Purpose

Penicillin Allergy, Pediatric Emergency Medicine

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Amoxicillin

About this trial

This is an interventional diagnostic trial for Penicillin Allergy

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

David Vyles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Challenge

Arm Description

Patients getting amoxicillin

Outcomes

Primary Outcome Measures

Oral amoxicillin challenge

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

Secondary Outcome Measures

Oral amoxicillin challenge follow-up

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.

Cost analysis

Examine whether health care outcomes and prescription-related costs associated with illness treatment plans 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 pediatric emergency department.

Full Information

NCT ID

NCT03404804

First Posted

January 12, 2018

Last Updated

April 27, 2021

Sponsor

Medical College of Wisconsin

1. Study Identification

Unique Protocol Identification Number

NCT03404804

Brief Title

Oral Challenge in the Pediatric ED

Acronym

OPEN

Official Title

Oral Penicillin Challenge in the Pediatric Emergency Department

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 4, 2017 (Actual)

Primary Completion Date

December 4, 2020 (Actual)

Study Completion Date

December 4, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Our primary objective is 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 project began as a single site feasibility study, however it has now transitioned to include 2 other collaborative sites for enrollment. We have entered into a single IRB with 1 of the collaborative sites. The other site has elected to do their own IRB. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Penicillin Allergy, Pediatric Emergency Medicine

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Challenge

Arm Type

Experimental

Arm Description

Patients getting amoxicillin

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Intervention Description

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

Primary Outcome Measure Information:

Title

Oral amoxicillin challenge

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Oral amoxicillin challenge follow-up

Description

Time Frame

1 year

Title

Cost analysis

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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. 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.

Facility Information:

Facility Name

David Vyles

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31586667

Citation

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.

Results Reference

derived

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