Oral Penicillin Challenge and Allergy De-labeling in Children

Phoenix Children's Hospital

Status and phase: Terminated; Phase 4

Conditions: Penicillin Allergy

Treatments: Drug: Amoxicillin 500mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05563610

IRB-22-154

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Oral Challenge

Experimental group

Description:

Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge.

Treatment:

Drug: Amoxicillin 500mg

No Oral Challenge

No Intervention group

Description:

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..