Oral Penicillin Challenge and Allergy De-labeling in Children

NCT ID: NCT05563610

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2024-06-12

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.

Conditions

Penicillin Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Oral Challenge

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

Group Type: EXPERIMENTAL

Amoxicillin 500mg

Intervention Type: DRUG

Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not

No Oral Challenge

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..

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Amoxicillin 500mg

Patients screened to be low risk of penicillin allergy will be randomized to receive amoxicillin dose or not

Intervention Type: DRUG

Other Intervention Names

Oral Challenge

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phoenix Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Diane E. Hindman, MD

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diane E Hindman, MD PharmD

Role: PRINCIPAL_INVESTIGATOR

Emergency Department Attending Physician

Locations

Phoenix Children's

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

IRB-22-154

Identifier Type: -

Identifier Source: org_study_id