Penicillin Allergy Clinical Trial
Official title:
Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy
Verified date | June 2021 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
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