CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
Amoxicillindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05010304
NCT05010304Phase 4Completed

Penicillin De-labeling in the Pediatric Primary Care Setting

University of Texas Southwestern Medical Center·interventional·Posted Aug 18, 2021·Updated Aug 14, 2024

In Brief

A Phase 4 clinical trial evaluating Amoxicillin for Penicillin Allergy and Penicillin Reaction. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedAug 18, 2021
Enrollment StartDec 9, 2021
Primary CompletionOct 31, 2023
Study CompletionNov 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.9 years ago

Interventions

Amoxicillindrug

Two-dose amoxicillin challenge