Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT03404804
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oral Challenge in the Pediatric ED
Sponsor:
Medical College of Wisconsin
Organization:
Study Overview
Official Title:
Oral Penicillin Challenge in the Pediatric Emergency Department
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPEN
Brief 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.
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.
Detailed Description:
A convenience sample of children aged 2 to 16 years who presented to the pediatric emergency department with a reported PCN allergy were administered an allergy questionnaire to determine risk-level designation. Low-risk eligible patients were offered an oral amoxicillin challenge. Differences among sites for family and provider interest in participation with oral challenges were analyzed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: