NCT05010304

Penicillin De-labeling in the Pediatric Primary Care Setting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Penicillin Allergy
• Penicillin Reaction

Interventions

Type	Name	Description
DRUG	Amoxicillin	Two-dose amoxicillin challenge

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-10-31
• Completion: 2023-11-30
• First posted: 2021-08-18
• Last updated: 2024-08-14
• Results posted: 2024-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study