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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Challenge | Experimental | Patients with low-risk symptoms of amoxicillin allergy who receive oral amoxicillin to delabel their respective allergy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result | Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit with insignificant adverse result. | 1 and 7 day followup phone surveys were conducted. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure | Conduct follow-up 6 months and 12 months after oral challenge for all children 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Vyles, DO, MS | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Vyles | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31586667 | Derived | Vyles D, Chiu A, Routes J, Castells M, Phillips EJ, Visotcky A, Fraser R, Pezzin L, Brousseau DC. Oral amoxicillin challenges in low-risk children during a pediatric emergency department visit. J Allergy Clin Immunol Pract. 2020 Mar;8(3):1126-1128.e1. doi: 10.1016/j.jaip.2019.09.022. Epub 2019 Oct 3. No abstract available. |
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Here at CHW we documented 130 subjects who were only given the questionnaire to assess risk and were not oral challenged in the CHW ED. In March of 2020, the study questionnaire was adopted as standard of clinical care for any patients presenting with a history of penicillin allergy, thus the questionnaire portion of the study was no longer a research activity. However, if the assessed risk was low, patients were approached for participation in oral challenge and consented if agreeable
Eligible families were approached, consented, and then administered an allergy questionnaire. Research staff abstracted age and demographic characteristics from the medical record. Patients who met eligibility criteria and were deemed low-risk were offered an oral drug challenge with amoxicillin.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Challenge | Patients getting amoxicillin Amoxicillin: Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Challenge | Patients getting amoxicillin Amoxicillin: Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result | Demonstrate that a low-risk group of children with reported penicillin allergy will complete an oral penicillin challenge during a pediatric emergency department visit with insignificant adverse result. | Subjects who met inclusion/exclusion criteria, were confirmed to be low risk and agreed to be oral challenged. | Posted | Count of Participants | Participants | 1 and 7 day followup phone surveys were conducted. |
|
1 year after oral challenge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Challenge | Patients getting Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy. Two children (1.7%) had mild symptoms after challenge deemed consistent with an allergic reaction by the PED provider. Four children experienced mild symptoms deemed not related to an allergic reaction by the examining physician |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild symptoms not related to allergic reaction to oral challenge | Skin and subcutaneous tissue disorders | Systematic Assessment | Itching. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Vyles, DO | Medical College of Wisconsin | 414-266-2625 | dvyles@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2022 | Sep 6, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| 6 months and 12 months after oral challenge |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure | Conduct follow-up 6 months and 12 months after oral challenge for all children 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. | Determined to be eligible by risk survey and giving consent to participate. | Posted | Count of Participants | Participants | 6 months and 12 months after oral challenge |
|
|
|
| 0 |
| 116 |
| 0 |
| 116 |
| 2 |
| 116 |
|
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| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |