<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/NCT03784482</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0478</org_study_id>
    <nct_id>NCT03784482</nct_id>
  </id_info>
  <brief_title>Multiple Drug Hypersensitivity Syndrome</brief_title>
  <acronym>MDH</acronym>
  <official_title>Multiple Drug Hypersensitivity Syndrome in a Large Database</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug&#xD;
      hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated&#xD;
      drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the&#xD;
      basis of positive allergy tests are lacking.&#xD;
&#xD;
      Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a&#xD;
      large database.&#xD;
&#xD;
      Methods: All the patients who consulted and were tested in our Allergy Unit between September&#xD;
      1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy&#xD;
      work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD).&#xD;
      The frequency of MDH will be calculated, MDH patients will be described, the most frequent&#xD;
      associations of DHRs will be identified and analysed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To measure retrospectively the frequency of MDH patients in our database.</measure>
    <time_frame>1 day</time_frame>
    <description>The frequency of MDH patients (percentage) in the allergic group of patients will be calculated as the number of MDH patients divided by the number of monoallergic patients (frequency of MDH patients in allergic population)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure retrospectively the frequency of MDH patients in our database</measure>
    <time_frame>1 day</time_frame>
    <description>The frequency of MDH in common population will be calculated by will be calculated as the number of MDH patients divided by the number of patients that underwent diagnostic drug allergy testing within the same time frame (frequency of MDH patients in the whole population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To describe the MDH population, identify the most frequent associations of DHR</measure>
    <time_frame>1 day</time_frame>
    <description>In this MDH patients population we will : Count the number of female and male patient according to their sex (No unit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the MDH population, identify the most frequent associations of DHR</measure>
    <time_frame>1 day</time_frame>
    <description>In this MDH patients population we will : Most frequent associations of DHR (No unit)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To describe the MDH population, identify the most frequent associations of DHR</measure>
    <time_frame>1 day</time_frame>
    <description>In this MDH patients population we will : Count and classify the different form of DHR according to their severity with the Ring and Messsmer and Regiscar study group scoring. (No unit) (ex: number of patient with grade III anaphylaxis or number of patient with DRESS syndrome )</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Drug Allergy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient consulting in our allergy unit for a suspicion of drug hypersensitivity and who&#xD;
        underwent diagnostic drug allergy testing&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients who consulted at our allergy clinic (University Hospital of Montpellier,&#xD;
             France)&#xD;
&#xD;
          -  Between September 1996 and February 2018 with a clinical history suggestive of DHR&#xD;
&#xD;
          -  Who completed a tailored drug allergy work-up, (including a drug allergy&#xD;
             questionnaire, skin tests (STs) and drug provocation tests (DPTs)) and were diagnosed&#xD;
             with MDH.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  the DHR was due to a single component contained in 2 different drug formulations&#xD;
&#xD;
          -  in composed drugs;&#xD;
&#xD;
          -  there was possible cross-reactivity between the responsible drugs; (iv) the patient&#xD;
             had positive but non standardized nor validated (i.e. possibly irritant)&#xD;
&#xD;
          -  these STs were followed by a negative DPT;&#xD;
&#xD;
          -  DPTs with placebo were positive; (vii) doubtful tests were repeated and eventually&#xD;
             considered negative;&#xD;
&#xD;
          -  a single DHR was associated with one or more non-drug related contact allergies;&#xD;
&#xD;
          -  DPTs elicited subjective manifestations (i.e., isolated pruritus, headache, isolated&#xD;
             abdominal pain);&#xD;
&#xD;
          -  non-specific histamine release was suspected (e.g., chronic spontaneous -&#xD;
             desensitization, rather than a diagnostic work-up was preferred in order to meet the&#xD;
             urgent therapeutic needs of individual patients (HIV infected patients, cardiac&#xD;
             patients).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pascal DEMOLY, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital of Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>November 18, 2019</last_update_submitted>
  <last_update_submitted_qc>November 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Drug Hypersensitivity</keyword>
  <keyword>drug hypersensitivity</keyword>
  <keyword>antibiotics</keyword>
  <keyword>drug provocation tests</keyword>
  <keyword>skin tests</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drug Hypersensitivity Syndrome</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Drug 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/NCT03784482
org study id: RECHMPL18_0478
nct id: NCT03784482
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug
      hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated
      drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the
      basis of positive allergy tests are lacking.

      Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a
      large database.

      Methods: All the patients who consulted and were tested in our Allergy Unit between September
      1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy
      work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD).
      The frequency of MDH will be calculated, MDH patients will be described, the most frequent
      associations of DHRs will be identified and analysed.
observational model: Cohort
time perspective: Retrospective
measure: To measure retrospectively the frequency of MDH patients in our database.
time frame: 1 day
description: The frequency of MDH patients (percentage) in the allergic group of patients will be calculated as the number of MDH patients divided by the number of monoallergic patients (frequency of MDH patients in allergic population)
measure: To measure retrospectively the frequency of MDH patients in our database
time frame: 1 day
description: The frequency of MDH in common population will be calculated by will be calculated as the number of MDH patients divided by the number of patients that underwent diagnostic drug allergy testing within the same time frame (frequency of MDH patients in the whole population
measure: To describe the MDH population, identify the most frequent associations of DHR
time frame: 1 day
description: In this MDH patients population we will : Count the number of female and male patient according to their sex (No unit)
measure: To describe the MDH population, identify the most frequent associations of DHR
time frame: 1 day
description: In this MDH patients population we will : Most frequent associations of DHR (No unit)
measure: To describe the MDH population, identify the most frequent associations of DHR
time frame: 1 day
description: In this MDH patients population we will : Count and classify the different form of DHR according to their severity with the Ring and Messsmer and Regiscar study group scoring. (No unit) (ex: number of patient with grade III anaphylaxis or number of patient with DRESS syndrome )
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pascal DEMOLY, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Drug Hypersensitivity Syndrome
mesh term: Hypersensitivity
mesh term: Drug Hypersensitivity
sharing ipd: No