NCT04441021

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 0 Years
• Healthy volunteers: Accepted

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.

Conditions

• Penicillin Allergy

Interventions

Type	Name	Description
OTHER	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

Timeline

• Start date: 2020-09-15
• Primary completion: 2020-12-01
• Completion: 2021-06-29
• First posted: 2020-06-22
• Last updated: 2021-06-30

Locations

1 site across 1 country: United States