Oral Penicillin Challenge and Allergy De-labeling in Children

Penicillin Allergy Clinical Trial

Official title:

Oral Penicillin Challenge and Allergy De-labeling in the Phoenix Children's Hospital Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563610
• Other study ID #: IRB-22-154
• Status: Recruiting
• Phase: Phase 4
• Start date: September 26, 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Phoenix Children's Hospital
• Contact: Diane E Hindman, MD PharmD
• Phone: 602-933-1950
• Email: dhindman[@]phoenixchildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Penicillin Allergy

Intervention

Drug:
• Amoxicillin 500mg
Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not

Locations

Country	Name	City	State
United States	Phoenix Children's	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Amoxicillin Oral Challenge Safety - High-Risk Reactions	Percentage of high-risk penicillin allergic reactions	24 hours after amoxicillin oral challenge
Secondary	Amoxicillin Oral Challenge Safety - Admissions	Percentage of admissions from the pediatric ED in patients experiencing high-risk penicillin allergic reactions	24 hours after amoxicillin oral challenge
Secondary	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
Secondary	Amoxicillin Oral Challenge Safety - Deaths	Percentage of deaths in patients experiencing high-risk penicillin allergic reactions	24 hours after amoxicillin oral challenge
Secondary	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