Penicillin De-labeling in the Pediatric Primary Care Setting

• ClinicalTrials.gov Identifier: NCT05010304
• Recruitment Status: Recruiting
• First Posted: August 18, 2021
• Last Update Posted: December 2, 2022
• Sponsor: University of Texas Southwestern Medical Center
• Collaborator: American College of Allergy, Asthma and Immunology
• Information provided by (Responsible Party): Timothy Chow, University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Penicillin Allergy; Penicillin Reaction	Drug: Amoxicillin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Penicillin De-labeling in the Pediatric Primary Care Setting
• Actual Study Start Date: December 9, 2021
• Estimated Primary Completion Date: October 31, 2023
• Estimated Study Completion Date: November 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Texas

Children's Medical Center Dallas; Recruiting

Dallas, Texas, United States, 75235

Contact: Timothy Chow, MD 214-456-2084 timothy.chow@utsouthwestern.edu

Principal Investigator: Timothy Chow, MD

Sponsors and Collaborators

University of Texas Southwestern Medical Center

American College of Allergy, Asthma and Immunology

More Information

• Responsible Party: Timothy Chow, Assistant Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT05010304
• Other Study ID Numbers: STU-2021-0517
• First Posted: August 18, 2021
• Last Update Posted: December 2, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Timothy Chow, University of Texas Southwestern Medical Center:

penicillin; allergy

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases; Amoxicillin; Anti-Bacterial Agents; Anti-Infective Agents