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Oral Penicillin Challenge and Allergy De-labeling in Children

Primary Purpose

Penicillin Allergy

Status

Active

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Amoxicillin 500mg

About this trial

This is an interventional diagnostic trial for Penicillin Allergy focused on measuring penicillin, anaphylaxis, allergy, oral challenge, amoxicillin, pediatric, emergency department

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies)
Patients at low risk of anaphylaxis as determined by the study questionnaire
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.
Patients who are interested in participating
Patients who have an acceptable surrogate to give consent on the subject's behalf
Patients whose surrogate (parent/caregiver) speaks English or Spanish

Exclusion Criteria:

Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate
Patients who have multiple drug allergies

Sites / Locations

Phoenix Children's

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oral Challenge

No Oral Challenge

Arm Description

Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg 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..

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Amoxicillin Oral Challenge Safety - High-Risk Reactions

Percentage of high-risk penicillin allergic reactions

Amoxicillin Oral Challenge Safety - Admissions

Percentage of admissions from the pediatric ED in patients experiencing high-risk penicillin allergic reactions

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

Amoxicillin Oral Challenge Safety - Deaths

Percentage of deaths in patients experiencing high-risk penicillin allergic reactions

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

Full Information

NCT ID

NCT05563610

First Posted

September 27, 2022

Last Updated

September 29, 2022

Sponsor

Phoenix Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05563610

Brief Title

Oral Penicillin Challenge and Allergy De-labeling in Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 26, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Phoenix Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Penicillin Allergy

Keywords

penicillin, anaphylaxis, allergy, oral challenge, amoxicillin, pediatric, emergency department

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oral Challenge

Arm Type

Experimental

Arm Description

Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge.

Arm Title

No Oral Challenge

Arm Type

No Intervention

Arm Description

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..

Intervention Type

Drug

Intervention Name(s)

Amoxicillin 500mg

Other Intervention Name(s)

Oral Challenge

Intervention Description

Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not

Primary Outcome Measure Information:

Title

True Penicillin Allergies

Description

Percentage of study patients presenting to the pediatric ED who received the amoxicillin oral challenge who demonstrated a true IgE-mediated allergic reaction

Time Frame

24 hours after amoxicillin oral challenge

Secondary Outcome Measure Information:

Title

Amoxicillin Oral Challenge Safety - High-Risk Reactions

Description

Percentage of high-risk penicillin allergic reactions

Time Frame

24 hours after amoxicillin oral challenge

Title

Amoxicillin Oral Challenge Safety - Admissions

Description

Percentage of admissions from the pediatric ED in patients experiencing high-risk penicillin allergic reactions

Time Frame

24 hours after amoxicillin oral challenge

Title

Amoxicillin Oral Challenge Safety - Re-admissions

Description

Percentage of re-admissions from home after discharge from the pediatric ED in patients experiencing high-risk penicillin allergic reactions

Time Frame

24 hours after amoxicillin oral challenge

Title

Amoxicillin Oral Challenge Safety - Deaths

Description

Percentage of deaths in patients experiencing high-risk penicillin allergic reactions

Time Frame

24 hours after amoxicillin oral challenge

Title

Amoxicillin Oral Challenge Feasibility

Description

Average hospital length of stay in the pediatric ED for patients receiving the amoxicillin oral challenge relative to the non-treatment group

Time Frame

24 hours after amoxicillin oral challenge

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Participants are eligible based on their self-representation of gender identity.

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies) Patients at low risk of anaphylaxis as determined by the study questionnaire 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. Patients who are interested in participating Patients who have an acceptable surrogate to give consent on the subject's behalf Patients whose surrogate (parent/caregiver) speaks English or Spanish Exclusion Criteria: Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate Patients who have multiple drug allergies

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diane E Hindman, MD PharmD

Organizational Affiliation

Emergency Department Attending Physician

Official's Role

Principal Investigator

Facility Information:

Facility Name

Phoenix Children's

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share IPD with other researchers at this time.

Learn more about this trial

Oral Penicillin Challenge and Allergy De-labeling in Children

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