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

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ClinicalTrials.gov Identifier: NCT04441021
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
James Antoon, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Penicillin Allergy Other: Penicillin Allergy Risk Stratification and Evaluation

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Penicillins

Group/Cohort Intervention/treatment
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
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




Primary Outcome Measures :
  1. Feasibility of Intervention Measure [ Time Frame: Within 2 weeks of hospital discharge ]
    Qualitative survey to assess feasibility of intervention


Secondary Outcome Measures :
  1. Acceptability of Intervention Measure [ Time Frame: Within 2 weeks of hospital discharge ]
    Qualitative survey to assess acceptability of intervention

  2. Intervention Appropriateness Measure [ Time Frame: Within 2 weeks of hospital discharge ]
    Qualitative survey to assess appropriateness of intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441021


Contacts
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Contact: James Antoon, MD, PhD 615-936-3898 james.antoon@vumc.org
Contact: Justine C Stassun 615-936-7276 justine.c.stassun@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: James Antoon, MD, PhD Vanderbilt University Medical Center
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Responsible Party: James Antoon, Assistant Professor, Pediatrics, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04441021    
Other Study ID Numbers: 200251-2
5K12HL137943-03 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents