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OpenTrials
Completed

NCT Number: NCT05010304

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amoxicillin

Drug

Two-dose amoxicillin challenge

Primary outcomes

  1. Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting

    Time frame: Day 1

  2. Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting

    Time frame: Day 1

Secondary outcomes

  1. Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge

    Time frame: 10-14 months after amoxicillin challenge

    Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • American College of Allergy, Asthma and Immunology

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 18, 2021
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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