Penicillin De-labeling in the Pediatric Primary Care Setting

While reported adverse reactions to penicillins are common, most patients with a penicillin allergy label can safely tolerate penicillins, and elective evaluation for penicillin allergy has been recommended. For low-risk patients, direct oral challenge may be an optimal approach as a delabeling strategy. However, there is a vast disparity between the number of patients with a penicillin allergy label and practicing allergists in the United States, and implementing outpatient primary care-based delabeling strategies in low-risk patients may increase access to delabeling assessments. However, a recent survey of pediatricians identified perceived barriers to implementing penicillin allergy evaluations into their routine care. Significant gaps in knowledge exist regarding the feasibility of this approach involving risk stratification evaluation of reported penicillin adverse reactions and direct amoxicillin challenge procedures in low-risk patients in the pediatric primary care setting. With this, the primary aim of this study is to evaluate the number of patients for which risk-stratification and direct amoxicillin challenge are successfully completed in an outpatient pediatric primary care clinic.

Study Overview

• Status: Completed
• Conditions: Penicillin Allergy; Penicillin Reaction
• Intervention / Treatment: Drug: Amoxicillin

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children from ages 2-18 years with a history of parent-reported penicillin allergy.

Exclusion Criteria:

• Children with a history of reaction consistent with a severe cutaneous adverse reaction to penicillin as defined as a history of oral blisters, diffuse skin peeling or blisters after taking a penicillin, or having the diagnosis of Stevens Johnson Syndrome, Toxic Epidermal Necrolysis, Drug rash with eosinophilia and systemic symptoms will be excluded. Pregnant and breastfeeding female subjects will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric Patients with a history of penicillin allergy	Drug: Amoxicillin; Two-dose amoxicillin challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Subjects who complete risk-stratification of penicillin allergy in the pediatric primary care setting	Day 1
Subjects stratified as low-risk with a negative immediate amoxicillin challenge in the pediatric primary care setting	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penicillin allergy labeling in subjects with negative amoxicillin challenge	Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge.	10-14 months after amoxicillin challenge

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: American College of Allergy, Asthma and Immunology

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: allergy; penicillin
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: STU-2021-0517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No