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

NCT04441021 | Completed

• 2 other identifiers: 200251-25K12HL137943-03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (1)

• Feasibility of Intervention Measure

  Qualitative survey to assess feasibility of intervention

  Within 2 weeks of hospital discharge

Secondary Outcomes (2)

• Acceptability of Intervention Measure

  Within 2 weeks of hospital discharge

• Intervention Appropriateness Measure

  Within 2 weeks of hospital discharge

Study Arms (1)

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

Other: Penicillin Allergy Risk Stratification and Evaluation

Interventions

Penicillin Allergy Risk Stratification and Evaluation OTHER

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

Penicillin Allergy Risk Stratification and Evaluation

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals 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

You may qualify if:

• 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

You may not qualify if:

• Known pregnancy
• Patients without a primary care provider

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Antoon JW, Grijalva CG, Grisso AG, Stone CA, Johnson J, Stassun J, Norton AE, Kripalani S, Williams DJ. Feasibility of a Centralized, Pharmacy-Led Penicillin Allergy Delabeling Program. Hosp Pediatr. 2022 Jul 1;12(7):e230-e237. doi: 10.1542/hpeds.2021-006369.

  PMID: 35678128 DERIVED

Study Officials

• James Antoon, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatrics

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: September 15, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 29, 2021
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)