A Phase 4 interventional study of Amoxicillin in Penicillin Allergy and Pediatric Emergency Medicine, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Medical College of Wisconsin · Phase 4, Interventional, and Diagnostic
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.
Exclusion Criteria:
Patients with low-risk symptoms of amoxicillin allergy who receive oral amoxicillin to delabel their respective allergy.
Drug: Amoxicillin
Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
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.
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
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.
| Milestone | Oral Challenge |
|---|---|
| Started | 116 |
| Completed | 116 |
| Not completed | 0 |
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.
| Participants | Oral Challenge |
|---|---|
| Number of subjects who tolerated an oral challenge without demonstrating allergy. | 114 |
| Children who had mild symptoms after challenge deemed to be an allergic reaction. | 2 |
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.
| Participants | Oral Challenge |
|---|---|
| number of children who tolerated an oral amoxicillin challenge | 114 |
| Number of subjects who developed allergy symptoms. | 2 |
Collected over 1 year after oral challenge.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Challenge | 0/116 (0%) | 0/116 (0%) | 2/116 (1.7%) |
| Event | Oral Challenge |
|---|---|
| mild symptoms not related to allergic reaction to oral challengeSkin and subcutaneous tissue disorders | 2/116 |
| Age, Categorical(Participants) | Oral Challenge |
|---|---|
| <=18 years | 116 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Oral Challenge |
|---|---|
| Mean | 9 ± 4 |
| Sex: Female, Male(Participants) | Oral Challenge |
|---|---|
| Female | 56 |
| Male | 60 |
| Race/Ethnicity, Customized(Participants) | Oral Challenge |
|---|---|
| white | 67 |
| African American | 25 |
| Hispanic | 15 |
| unknown | 9 |
| Region of Enrollment(participants) | Oral Challenge |
|---|---|
| United States | 116 |
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Medical College of Wisconsin