Oral Penicillin Challenge and Allergy De-labeling in Children

Phase 4

Terminated

• Conditions: Penicillin Allergy
• Interventions: Drug: Amoxicillin 500mg

• Registration Number: NCT05563610
• Lead Sponsor: Phoenix Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-26
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-03
• Status Verified: 2024-06
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Challenge	Amoxicillin 500mg	Patients will be screened for high vs. low risk of penicillin allergy. Low risk patients will be randomized to oral amoxicillin 500 mg challenge.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Phoenix Children's; 🇺🇸 Phoenix, Arizona, United States