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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04441021
Enrollment
20
Registered
2020-06-22
Start date
2020-09-15
Completion date
2021-06-29
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Penicillin Allergy

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.

Interventions

OTHERPenicillin 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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of Intervention MeasureWithin 2 weeks of hospital dischargeQualitative survey to assess feasibility of intervention

Secondary

MeasureTime frameDescription
Acceptability of Intervention MeasureWithin 2 weeks of hospital dischargeQualitative survey to assess acceptability of intervention
Intervention Appropriateness MeasureWithin 2 weeks of hospital dischargeQualitative survey to assess appropriateness of intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026