Penicillin De-labeling in the Pediatric Primary Care Setting

Penicillin Allergy Clinical Trial

Official title:

Penicillin De-labeling in the Pediatric Primary Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05010304
• Other study ID #: STU-2021-0517
• Status: Completed
• Phase: Phase 4
• Start date: December 9, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 30, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Penicillin Allergy

Intervention

Drug:
• Amoxicillin
Two-dose amoxicillin challenge

Locations

Country	Name	City	State
United States	Children's Medical Center Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	American College of Allergy, Asthma and Immunology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects who complete risk-stratification of penicillin allergy in the pediatric primary care setting		Day 1
Primary	Subjects stratified as low-risk with a negative immediate amoxicillin challenge in the pediatric primary care setting		Day 1
Secondary	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