Penicillin Allergy
Conditions
Keywords
penicillin, anaphylaxis, allergy, oral challenge, amoxicillin, pediatric, emergency department
Brief summary
The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. The secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the Pediatric Emergency Department.
Interventions
Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not
Sponsors
Phoenix Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies) 2. Patients at low risk of anaphylaxis as determined by the study questionnaire 3. Patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, Group A Streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for Helicobacter pylori eradication, or other acute infections deemed susceptible. 4. Patients who are interested in participating 5. Patients who have an acceptable surrogate to give consent on the subject's behalf 6. Patients whose surrogate (parent/caregiver) speaks English or Spanish
Exclusion criteria
1. Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate 2. Patients who have multiple drug allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True Penicillin Allergies | 24 hours after amoxicillin oral challenge | Percentage of study patients presenting to the pediatric ED who received the amoxicillin oral challenge who demonstrated a true IgE-mediated allergic reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amoxicillin Oral Challenge Safety - High-Risk Reactions | 24 hours after amoxicillin oral challenge | Percentage of high-risk penicillin allergic reactions |
| Amoxicillin Oral Challenge Safety - Admissions | 24 hours after amoxicillin oral challenge | Percentage of admissions from the pediatric ED in patients experiencing high-risk penicillin allergic reactions |
| Amoxicillin Oral Challenge Safety - Re-admissions | 24 hours after amoxicillin oral challenge | Percentage of re-admissions from home after discharge from the pediatric ED in patients experiencing high-risk penicillin allergic reactions |
| Amoxicillin Oral Challenge Safety - Deaths | 24 hours after amoxicillin oral challenge | Percentage of deaths in patients experiencing high-risk penicillin allergic reactions |
| Amoxicillin Oral Challenge Feasibility | 24 hours after amoxicillin oral challenge | Average hospital length of stay in the pediatric ED for patients receiving the amoxicillin oral challenge relative to the non-treatment group |
Countries
United States
Outcome results
None listed