Phase 4
N=23
Penicillin De-labeling in the Pediatric Primary Care Setting
Penicillin Allergy · Penicillin Reaction
Bottom Line
View on ClinicalTrials.gov: NCT05010304 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting — 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Amoxicillin (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting |
23 | — |
| PRIMARY Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting |
21 | — |
| SECONDARY Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05010304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.