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Penicillin De-labeling in the Pediatric Primary Care Setting

Primary Purpose

Penicillin Allergy, Penicillin Reaction

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amoxicillin
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Penicillin Allergy focused on measuring penicillin, allergy

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Medical Center DallasRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatric Patients with a history of penicillin allergy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 10, 2021
Last Updated
December 1, 2022
Sponsor
University of Texas Southwestern Medical Center
Collaborators
American College of Allergy, Asthma and Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT05010304
Brief Title
Penicillin De-labeling in the Pediatric Primary Care Setting
Official Title
Penicillin De-labeling in the Pediatric Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
American College of Allergy, Asthma and Immunology

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy, Penicillin Reaction
Keywords
penicillin, allergy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pediatric Patients with a history of penicillin allergy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Two-dose amoxicillin challenge
Primary Outcome Measure Information:
Title
Subjects who complete risk-stratification of penicillin allergy in the pediatric primary care setting
Time Frame
Day 1
Title
Subjects stratified as low-risk with a negative immediate amoxicillin challenge in the pediatric primary care setting
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Penicillin allergy labeling in subjects with negative amoxicillin challenge
Description
Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge.
Time Frame
10-14 months after amoxicillin challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Chow, MD
Phone
214-456-2084
Email
timothy.chow@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Timothy Chow, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Penicillin De-labeling in the Pediatric Primary Care Setting

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