CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 116 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/NCT03404804
NCT03404804Phase 4Completed

Oral Penicillin Challenge in the Pediatric Emergency Department

Medical College of Wisconsin·interventional·Posted Jan 19, 2018·Updated May 16, 2024

In Brief

A Phase 4 clinical trial evaluating Amoxicillin for Penicillin Allergy and Pediatric Emergency Medicine. Completed, enrolled 116 participants across 1 site.

Detailed Summary

Our primary objective was to demonstrate the feasibility of utilizing a novel penicillin allergy questionnaire in the PED to identify a low-risk group of patients who will complete an oral challenge in the PED to test for an IgE-mediated allergic reaction. This was a 3-site pediatric emergency department study in which we challenged patients who met specific inclusion and exclusion criteria and were deemed low-risk. Original aims included: Aim 1: Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit. Aim 2: Conduct follow-up one day after oral challenge for all children and seven days after oral challenge for patients discharged with a prescription antibiotic to determine if a delayed or T-Cell mediated reaction occurs after exposure to multiple doses of penicillin or any other antibiotic prescribed at discharge. Aim 3: Examine health care outcomes and prescription-related costs associated with illness treatment plans in children who are de-labeled as penicillin allergic after an oral challenge. A secondary objective within the IRB protocol reports, "Our secondary objective is to examine whether health care outcomes and prescription-related costs are comparable between children who are de-labeled as penicillin allergic after an oral challenge compared to a standard of care group who are not challenged in the PED." However, we never proceeded with enrolling patients with PCN allergy not challenged in the PED as it was planned for later in the study that did not come to fruition.

Study Details

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

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 19, 2018
Enrollment StartDec 4, 2017
Primary CompletionDec 4, 2020
Study CompletionDec 4, 2022
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 8.5 years ago

Interventions

Amoxicillindrug

Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy