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Completed No phase listed Observational Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04441021

Public ClinicalTrials.gov record NCT04441021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 6:30 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04441021
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
20 participants

Conditions and interventions

Eligibility (public fields only)

Age range
0 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2020
Primary completion
Nov 30, 2020
Completion
Jun 28, 2021
Last update posted
Jun 29, 2021

2020 – 2021

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Vanderbilt University Medical Center Nashville Tennessee 37232

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04441021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 29, 2021 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04441021 live on ClinicalTrials.gov.

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