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Oral Penicillin Challenge and Allergy De-labeling in Children

NCT05563610 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-06-14

No results posted yet for this study

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

Interventions

DRUG

Amoxicillin 500mg

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

Sponsors & Collaborators

  • Phoenix Children's Hospital

    lead OTHER

Principal Investigators

  • Diane E Hindman, MD PharmD · Emergency Department Attending Physician

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2024-06-12
Completion
2024-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05563610 on ClinicalTrials.gov