Oral Penicillin Challenge and Allergy De-labeling in Children

NCT05563610 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: IRB-22-154
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Penicillin Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours after amoxicillin oral challenge

Secondary Outcomes (5)

• Amoxicillin Oral Challenge Safety - High-Risk Reactions

  24 hours after amoxicillin oral challenge

• Amoxicillin Oral Challenge Safety - Admissions

  24 hours after amoxicillin oral challenge

• Amoxicillin Oral Challenge Safety - Re-admissions

  24 hours after amoxicillin oral challenge

• Amoxicillin Oral Challenge Safety - Deaths

  24 hours after amoxicillin oral challenge

• Amoxicillin Oral Challenge Feasibility

  24 hours after amoxicillin oral challenge

Study Arms (2)

Oral Challenge

EXPERIMENTAL

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

Drug: Amoxicillin 500mg

No Oral Challenge

NO INTERVENTION

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..

Interventions

Amoxicillin 500mg DRUG

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

Also known as: Oral Challenge

Oral Challenge

Eligibility Criteria

• Age: 2 Years - 17 Years
• Gender Eligibility Details: Participants are eligible based on their self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (1)

Phoenix Children's

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Anaphylaxis; Hypersensitivity; Emergencies

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Officials

• Diane E Hindman, MD PharmD

  Emergency Department Attending Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 3, 2022
• Study Start: September 26, 2022
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)