<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/NCT02983630</url>
  </required_header>
  <id_info>
    <org_study_id>4479</org_study_id>
    <nct_id>NCT02983630</nct_id>
  </id_info>
  <brief_title>Allergy Testing of Patients Labeled as Penicillin Allergic</brief_title>
  <official_title>Allergy Testing of Primary Care Patients Labeled as Penicillin Allergic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albany Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albany Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as&#xD;
      &quot;penicillin allergic&quot; is associated with increased health care costs, adverse effects and&#xD;
      antibiotic resistance. The investigators will recruit participants from primary care&#xD;
      practices labeled as penicillin allergic and offer allergy testing. The aim of this study is&#xD;
      to develop a community, outpatient program for evaluation of penicillin allergy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Allergy testing for penicillin allergy results</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction after allergy testing with follow-up questionnaire</measure>
    <time_frame>Within 6 months following testing</time_frame>
    <description>A questionnaire will be provided to participants to review their experience with penicillin allergy testing, whether they will take penicillin in the future and if it is valuable information to be tested. Answers will be yes and no. This information will tell us</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of new drug allergies following negative testing questionnaire</measure>
    <time_frame>6 months-2 years</time_frame>
    <description>Follow-up questionnaire will be sent to participants to evaluate whether they have needed any antibiotics and if so, whether they've had any reactions. This will be two yes/no questions to assess the incidence of development of new allergic reaction following negative testing.</description>
  </secondary_outcome>
  <enrollment type="Actual">37</enrollment>
  <condition>Drug Hypersensitivity</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Penicillin allergy testing</intervention_name>
    <description>The standard protocol for testing for penicillin hypersensitivity, including initial skin testing with prick and intradermal evaluation followed by oral challenge if skin testing is negative.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults ages 18 and older from the general population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Labeled as having penicillin or amoxicillin allergy&#xD;
&#xD;
          2. Family history of penicillin allergy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of beta-lactam associated toxic epidermal necrolysis/Stevens Johnson syndrome&#xD;
             to penicillin or amoxicillin&#xD;
&#xD;
          2. History of Drug induced Eosinophilia with Systemic Symptoms (DRESS)&#xD;
&#xD;
          3. History of drug induced: autoimmune hepatitis/interstitial nephritis, or hemolytic&#xD;
             anemia&#xD;
&#xD;
          4. Poorly controlled asthma or heart disease&#xD;
&#xD;
          5. Currently pregnant&#xD;
&#xD;
          6. Unable to discontinue certain medications that may interfere with testing including&#xD;
             (antihistamines, steroids, beta-blockers, tricyclic antidepressants, omalizumab)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Albany Medical College Allergy, Asthma and Immunology Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albany Medical College</investigator_affiliation>
    <investigator_full_name>Britta Sundquist</investigator_full_name>
    <investigator_title>Instructor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Drug 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>
  <!-- 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/NCT02983630
org study id: 4479
nct id: NCT02983630
lead sponsor: 
has dmc: No
Patients labeled as penicillin allergic, rarely have this confirmed and being labeled as
      "penicillin allergic" is associated with increased health care costs, adverse effects and
      antibiotic resistance. The investigators will recruit participants from primary care
      practices labeled as penicillin allergic and offer allergy testing. The aim of this study is
      to develop a community, outpatient program for evaluation of penicillin allergy.
observational model: Cohort
time perspective: Prospective
measure: Allergy testing for penicillin allergy results
time frame: 6 months
measure: Participant satisfaction after allergy testing with follow-up questionnaire
time frame: Within 6 months following testing
description: A questionnaire will be provided to participants to review their experience with penicillin allergy testing, whether they will take penicillin in the future and if it is valuable information to be tested. Answers will be yes and no. This information will tell us
measure: Development of new drug allergies following negative testing questionnaire
time frame: 6 months-2 years
description: Follow-up questionnaire will be sent to participants to evaluate whether they have needed any antibiotics and if so, whether they've had any reactions. This will be two yes/no questions to assess the incidence of development of new allergic reaction following negative testing.
intervention type: Other
intervention name: Penicillin allergy testing
description: The standard protocol for testing for penicillin hypersensitivity, including initial skin testing with prick and intradermal evaluation followed by oral challenge if skin testing is negative.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albany Medical College
investigator full name: Britta Sundquist
investigator title: Instructor of Medicine
mesh term: Hypersensitivity
mesh term: Drug Hypersensitivity
mesh term: Penicillins