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Unable to recruit sufficient number of subjects in the setting
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Challenge | Experimental | Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge. |
|
| No Oral Challenge | No Intervention | Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to no oral amoxicillin 500 mg challenge.. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin 500mg | Drug | Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not |
|
| Measure | Description | Time Frame |
|---|---|---|
| True Penicillin Allergies | Percentage of study patients presenting to the pediatric ED who received the amoxicillin oral challenge who demonstrated a true IgE-mediated allergic reaction | 24 hours after amoxicillin oral challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Amoxicillin Oral Challenge Safety - High-Risk Reactions | Percentage of high-risk penicillin allergic reactions | 24 hours after amoxicillin oral challenge |
| Amoxicillin Oral Challenge Safety - Admissions |
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Inclusion Criteria:
Exclusion Criteria:
Participants are eligible based on their self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Diane E Hindman, MD PharmD | Emergency Department Attending Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's | Phoenix | Arizona | 85016 | United States |
There is no plan to share IPD with other researchers at this time.
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| ID | Term |
|---|---|
| D000707 | Anaphylaxis |
| D006967 | Hypersensitivity |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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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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Percentage of admissions from the pediatric ED in patients experiencing high-risk penicillin allergic reactions
| 24 hours after amoxicillin oral challenge |
| Amoxicillin Oral Challenge Safety - Re-admissions | Percentage of re-admissions from home after discharge from the pediatric ED in patients experiencing high-risk penicillin allergic reactions | 24 hours after amoxicillin oral challenge |
| Amoxicillin Oral Challenge Safety - Deaths | Percentage of deaths in patients experiencing high-risk penicillin allergic reactions | 24 hours after amoxicillin oral challenge |
| Amoxicillin Oral Challenge Feasibility | Average hospital length of stay in the pediatric ED for patients receiving the amoxicillin oral challenge relative to the non-treatment group | 24 hours after amoxicillin oral challenge |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |