Pediatric Emergency Medicine, Penicillin Allergy
Conditions
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.
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.
Interventions
DRUGAmoxicillin
Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
Sponsors
Medical College of Wisconsin
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 2-16 with a parent/guardian (hereafter termed parent) reported history of allergy to a penicillin antibiotic in which the reported allergic reaction occurred at least six months prior to the current PED visit. * Only children well enough to be discharged to home at the conclusion of the PED visit are eligible.
Exclusion criteria
* Children will be excluded if they have a history of developmental delay or inability to communicate the effects of an allergic reaction (non-verbal). * Any contraindication to allergy testing will also result in exclusion * (i.e. history of a severe allergic reaction to skin tests,, * anaphylaxis in the past six weeks, * known pregnancy * child has a history of a condition that requires a beta blocker medicine for cardiac conditions, high blood pressure, migraine headaches, or eye drops for glaucoma (e.g. propranolol, metoprolol, atenolol and Timoptic®, or Betoptic® eye drops). * Children who present to the PED with a rash, vomiting or current asthma symptoms including coughing, wheezing or breathing problems will also be excluded to ensure these do not mask reactions to an oral challenge. * Patients deemed too acutely ill for participation (triage level 1 or 2 or as determined by the ED patient care team) will be excluded from the study. * During this pilot study, we will exclude non-English speaking families. However, in subsequent studies we will include the non-English speaking population. * Children who are wards of the state, in foster care or police custody or detention will be excluded. * Children with any basal condition (trauma, infection, minor accidents, etc..) will be able to participate in the study provided they and their family are willing and do not meet the above-mentioned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result | 1 and 7 day followup phone surveys were conducted. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure | 6 months and 12 months after oral challenge | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Oral Challenge Patients getting amoxicillin
Amoxicillin: Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy | 116 |
| Total | 116 |
Baseline characteristics
| Characteristic | Oral Challenge |
|---|---|
| Age, Categorical <=18 years | 116 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9 years STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized African American | 25 Participants |
| Race/Ethnicity, Customized Hispanic | 15 Participants |
| Race/Ethnicity, Customized unknown | 9 Participants |
| Race/Ethnicity, Customized white | 67 Participants |
| Region of Enrollment United States | 116 participants |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 116 |
| other Total, other adverse events | 2 / 116 |
| serious Total, serious adverse events | 0 / 116 |
Outcome results
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.
Time frame: 1 and 7 day followup phone surveys were conducted.
Population: Subjects who met inclusion/exclusion criteria, were confirmed to be low risk and agreed to be oral challenged.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Challenge | Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result | Number of subjects who tolerated an oral challenge without demonstrating allergy. | 114 Participants |
| Oral Challenge | Number of Oral Amoxicillin Challenge Participants Completing Challenge With Insignificant Adverse Result | Children who had mild symptoms after challenge deemed to be an allergic reaction. | 2 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.
Time frame: 6 months and 12 months after oral challenge
Population: Determined to be eligible by risk survey and giving consent to participate.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Challenge | Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure | number of children who tolerated an oral amoxicillin challenge | 114 Participants |
| Oral Challenge | Number of Participants With Oral Amoxicillin Challenge Follow-up to Determine if a Delayed or T-Cell Mediated Reaction Occurs After Exposure | Number of subjects who developed allergy symptoms. | 2 Participants |