Penicillin De-labeling in the Pediatric Primary Care Setting

NCT05010304 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STU-2021-0517
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Penicillin Allergy; Penicillin Reaction

Keywords

penicillin; allergy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge

  10-14 months after amoxicillin challenge

Study Arms (1)

Pediatric Patients with a history of penicillin allergy

EXPERIMENTAL

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

Two-dose amoxicillin challenge

Pediatric Patients with a history of penicillin allergy

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American College of Allergy, Asthma and Immunology: collaborator

Study Sites (1)

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Chow TG, Patel G, Mohammed M, Johnson D, Khan DA. Delabeling penicillin allergy in a pediatric primary care clinic. Ann Allergy Asthma Immunol. 2023 May;130(5):667-669. doi: 10.1016/j.anai.2023.01.034. Epub 2023 Feb 2. No abstract available.

  PMID: 36738783 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Immune System Diseases

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

Results Point of Contact

• Title: Dr Timothy Chow
• Organization: University of Texas Southwestern

timothy.chow@utsouthwestern.edu

2144569093

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 18, 2021
• Study Start: December 9, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)