Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy

Completed

• Conditions: Penicillin Allergy
• Interventions: Other: Penicillin Allergy Risk Stratification and Evaluation

• Registration Number: NCT04441021
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic. Recent studies have demonstrated that a large majority of children with a penicillin allergy label do not have a true IgE-mediated allergy. Appropriately delabeling antibiotic allergies has been shown to improve patient care outcomes and lower health care costs. However, efforts to implement these assessments in practice are lacking, particularly in the hospital setting. Therefore, there is a need for hospital-based risk assessment and delabeling strategies for hospitalized children. The investigator's objective is to determine the feasibility of implementing a hospital-based approach to penicillin allergy risk stratification and evaluation of patients at low-risk for true allergy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-22
• Study Start: 2020-09-15
• Primary Completion: 2020-12-01
• Status Verified: 2021-06
• Study Completion: 2021-06-29
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients admitted to Vanderbilt children's hospital admitted to a Pediatric Hospital Medicine service with a penicillin allergy reported in their chart who are medically stable

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Exclusion Criteria

• Known pregnancy
• Patients without a primary care provider

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Penicillin Allergy Risk Stratification and Evaluation	Penicillin Allergy Risk Stratification and Evaluation	This standard of care intervention will provide an antibiotic allergy risk stratification assessment and subsequent amoxicillin oral challenge in patients who stratify as low risk for true allergy

Primary Outcome Measures

Name	Time	Method
Feasibility of Intervention Measure	Within 2 weeks of hospital discharge	Qualitative survey to assess feasibility of intervention

Secondary Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure	Within 2 weeks of hospital discharge	Qualitative survey to assess acceptability of intervention
Intervention Appropriateness Measure	Within 2 weeks of hospital discharge	Qualitative survey to assess appropriateness of intervention

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States