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

Penicillin Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441021
• Other study ID #: 200251-2
• Secondary ID: 5K12HL137943-03
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: June 29, 2021

Study information

• Verified date: June 2021
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 29, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Exclusion Criteria:

• Known pregnancy

• Patients without a primary care provider

Related Conditions & MeSH terms

• Hypersensitivity
• Penicillin Allergy

Intervention

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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Intervention Measure	Qualitative survey to assess feasibility of intervention	Within 2 weeks of hospital discharge
Secondary	Acceptability of Intervention Measure	Qualitative survey to assess acceptability of intervention	Within 2 weeks of hospital discharge
Secondary	Intervention Appropriateness Measure	Qualitative survey to assess appropriateness of intervention	Within 2 weeks of hospital discharge