<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/NCT01667055</url>
  </required_header>
  <id_info>
    <org_study_id>Chula-ARC 002/12</org_study_id>
    <nct_id>NCT01667055</nct_id>
  </id_info>
  <brief_title>The Diagnosis of Beta-lactam Hypersensitivity in Thailand</brief_title>
  <official_title>The Optimized Diagnostic Methods for the Confirmation of Beta-lactam Hypersensitivity in Thailand</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The true prevalence of drug allergy in patients with a history of beta-lactam&#xD;
      hypersensitivity will be determined by using commercially available standard skin test&#xD;
      reagents and the diagnostic agents available in Thailand. We hypothesize that only minority&#xD;
      of patients with such a history are truly allergic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard&#xD;
      skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic&#xD;
      if applicable), and intravenous forms of beta-lactam antibiotics .&#xD;
&#xD;
      Diagnostic values of the measurement of specific Immunoglobulin E to&#xD;
      penicillin/aminopenicillin and skin test reagents currently available in Thailand will be&#xD;
      comparatively analyzed with the standard skin test reagents.&#xD;
&#xD;
      The measurement of drug-induced interferon-gamma releasing cells will be measured in patients&#xD;
      with a history of non-immediate reaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity</measure>
    <time_frame>1 year</time_frame>
    <description>The skin test positive rate in patients with a history of beta-lactam hypersensitivity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity</measure>
    <time_frame>1 year</time_frame>
    <description>The diagnostic values of skin testing, drug-specific Immunoglobulin E measurement, and interferon-gamma ELISpot assay for the diagnosis of beta-lactam hypersensitivity</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">500</enrollment>
  <condition>Penicillin Allergy</condition>
  <condition>Aminopenicillin Allergy</condition>
  <condition>Beta Lactam Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>Patients with suspected drug allergy</arm_group_label>
    <description>Patients with a history of hypersensitivity reaction to beta-lactam antibiotics</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood mononuclear cells in patients with a history of non-immediate reaction&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a history of beta-lactam hypersensitivity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of beta-lactam hypersensitivity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being pregnant&#xD;
&#xD;
          -  Having serious medical illnesses&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jettanong Klaewsongkram, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>October 27, 2019</last_update_submitted>
  <last_update_submitted_qc>October 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Assoc. Prof. Jettanong Klaewsongkram, MD.</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>drug allergy</keyword>
  <keyword>drug hypersensitivity</keyword>
  <keyword>beta-lactam allergy</keyword>
  <keyword>penicillin allergy</keyword>
  <keyword>adverse drug reaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_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/NCT01667055
org study id: Chula-ARC 002/12
nct id: NCT01667055
lead sponsor: 
has dmc: Yes
The true prevalence of drug allergy in patients with a history of beta-lactam
      hypersensitivity will be determined by using commercially available standard skin test
      reagents and the diagnostic agents available in Thailand. We hypothesize that only minority
      of patients with such a history are truly allergic.
Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard
      skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic
      if applicable), and intravenous forms of beta-lactam antibiotics .

      Diagnostic values of the measurement of specific Immunoglobulin E to
      penicillin/aminopenicillin and skin test reagents currently available in Thailand will be
      comparatively analyzed with the standard skin test reagents.

      The measurement of drug-induced interferon-gamma releasing cells will be measured in patients
      with a history of non-immediate reaction.
observational model: Cohort
time perspective: Cross-Sectional
measure: The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity
time frame: 1 year
description: The skin test positive rate in patients with a history of beta-lactam hypersensitivity
measure: Clinical values of various diagnostic modalities in patients with a history of beta-lactam hypersensitivity
time frame: 1 year
description: The diagnostic values of skin testing, drug-specific Immunoglobulin E measurement, and interferon-gamma ELISpot assay for the diagnosis of beta-lactam hypersensitivity
arm group label: Patients with suspected drug allergy
description: Patients with a history of hypersensitivity reaction to beta-lactam antibiotics
Peripheral blood mononuclear cells in patients with a history of non-immediate reaction
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Jettanong Klaewsongkram, MD
role: Principal Investigator
affiliation: Chulalongkorn University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Assoc. Prof. Jettanong Klaewsongkram, MD.
investigator title: Associate Professor
mesh term: Hypersensitivity
sharing ipd: No