<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04441021</url>
  </required_header>
  <id_info>
    <org_study_id>200251-2</org_study_id>
    <secondary_id>5K12HL137943-03</secondary_id>
    <nct_id>NCT04441021</nct_id>
  </id_info>
  <brief_title>Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy</brief_title>
  <official_title>Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children are often reported to have antibiotics allergies, with approximately 10% of the US&#xD;
      population labeled as allergic to an antibiotic. Recent studies have demonstrated that a&#xD;
      large majority of children with a penicillin allergy label do not have a true IgE-mediated&#xD;
      allergy. Appropriately delabeling antibiotic allergies has been shown to improve patient care&#xD;
      outcomes and lower health care costs. However, efforts to implement these assessments in&#xD;
      practice are lacking, particularly in the hospital setting. Therefore, there is a need for&#xD;
      hospital-based risk assessment and delabeling strategies for hospitalized children. The&#xD;
      investigator's objective is to determine the feasibility of implementing a hospital-based&#xD;
      approach to penicillin allergy risk stratification and evaluation of patients at low-risk for&#xD;
      true allergy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">June 29, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Intervention Measure</measure>
    <time_frame>Within 2 weeks of hospital discharge</time_frame>
    <description>Qualitative survey to assess feasibility of intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Intervention Measure</measure>
    <time_frame>Within 2 weeks of hospital discharge</time_frame>
    <description>Qualitative survey to assess acceptability of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Appropriateness Measure</measure>
    <time_frame>Within 2 weeks of hospital discharge</time_frame>
    <description>Qualitative survey to assess appropriateness of intervention</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Penicillin Allergy</condition>
  <arm_group>
    <arm_group_label>Penicillin Allergy Risk Stratification and Evaluation</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Penicillin Allergy Risk Stratification and Evaluation</intervention_name>
    <description>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</description>
    <arm_group_label>Penicillin Allergy Risk Stratification and Evaluation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals admitted to Vanderbilt children's hospital admitted to a Pediatric Hospital&#xD;
        Medicine service with a penicillin allergy reported in their chart who are medically stable&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to Vanderbilt children's hospital admitted to a Pediatric Hospital&#xD;
             Medicine service with a penicillin allergy reported in their chart who are medically&#xD;
             stable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Patients without a primary care provider&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Antoon, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>James Antoon</investigator_full_name>
    <investigator_title>Assistant Professor, Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Penicillins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04441021
org study id: 200251-2
secondary id: 5K12HL137943-03
nct id: NCT04441021
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Feasibility of Intervention Measure
time frame: Within 2 weeks of hospital discharge
description: Qualitative survey to assess feasibility of intervention
measure: Acceptability of Intervention Measure
time frame: Within 2 weeks of hospital discharge
description: Qualitative survey to assess acceptability of intervention
measure: Intervention Appropriateness Measure
time frame: Within 2 weeks of hospital discharge
description: Qualitative survey to assess appropriateness of intervention
arm group label: Penicillin Allergy Risk Stratification and Evaluation
description: 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
intervention type: Other
intervention name: Penicillin Allergy Risk Stratification and Evaluation
description: 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
arm group label: Penicillin Allergy Risk Stratification and Evaluation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Antoon, MD, PhD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: James Antoon
investigator title: Assistant Professor, Pediatrics
mesh term: Hypersensitivity
mesh term: Penicillins
sharing ipd: No