<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/NCT03771118</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL18_0434</org_study_id>
    <nct_id>NCT03771118</nct_id>
  </id_info>
  <brief_title>Drug Provocation Test (DPT) to Paracetamol</brief_title>
  <acronym>Paracetamol</acronym>
  <official_title>Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity</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 : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed&#xD;
      in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test&#xD;
      (DPT).&#xD;
&#xD;
      Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest&#xD;
      optimal step doses and to identify variables and potential risk factors associated with&#xD;
      Paracetamol hypersensitivity.&#xD;
&#xD;
      Methods:This retrospective study, using the survival analysis and the multivariate analysis,&#xD;
      will comprise all patients who attended the allergy service of the University Hospital of&#xD;
      Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who&#xD;
      underwent Paracetamol DPT and who gave their consent to be included in the study. The&#xD;
      patients are selected from the Drug Allergy &amp; Hypersensitivity Database (DAHD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Detect of the reactive dose (RD)</measure>
    <time_frame>1 day</time_frame>
    <description>The outcome measure of the RD : The dose that the patient reaches when the DPT is positive, divided by the total DPT dose for a given patient. This RD will be calculated for every patient with a positive DPT. New events (positive DPT) from one RD to another will be evaluated in number and severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure is a positive DPT to paracetamol</measure>
    <time_frame>1 day</time_frame>
    <description>Identifying clinical risk factors (Odds Ratio), using the binary logistic regression method, significantly associated with a positive Paracetamol DPT.&#xD;
Age at reaction, sex, presence of asthma and atopy, type and chronology of the initial reaction will be evaluated as potential risk factors. Risk factors of anaphylaxis during DPT will also be calculated, using the same variables.&#xD;
Potential variables to explain this measure will be introduced in a logistic model, in order to obtain crude and adjusted OR that could explain a positive DPT to paracetamol.</description>
  </secondary_outcome>
  <enrollment type="Actual">498</enrollment>
  <condition>Drug Hypersensitivity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient consulting in our allergy unit for a suspicion of drug hypersensitivity to&#xD;
        Paracetamol and who underwent DPT.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Patients with a positive or negative DPT to paracetamol&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients refusing to take part in the study&#xD;
&#xD;
          -  Patient under 10 years old&#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>March 2020</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Hypersensitivity Reaction</keyword>
  <keyword>Drug Provocation Test</keyword>
  <keyword>Paracetamol</keyword>
  <keyword>Reactive Doses</keyword>
  <keyword>Reactive Times</keyword>
  <keyword>Acetaminophen</keyword>
  <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>
  <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/NCT03771118
org study id: RECHMPL18_0434
nct id: NCT03771118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed
      in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test
      (DPT).

      Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest
      optimal step doses and to identify variables and potential risk factors associated with
      Paracetamol hypersensitivity.

      Methods:This retrospective study, using the survival analysis and the multivariate analysis,
      will comprise all patients who attended the allergy service of the University Hospital of
      Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who
      underwent Paracetamol DPT and who gave their consent to be included in the study. The
      patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).
observational model: Cohort
time perspective: Retrospective
measure: Detect of the reactive dose (RD)
time frame: 1 day
description: The outcome measure of the RD : The dose that the patient reaches when the DPT is positive, divided by the total DPT dose for a given patient. This RD will be calculated for every patient with a positive DPT. New events (positive DPT) from one RD to another will be evaluated in number and severity.
measure: Measure is a positive DPT to paracetamol
time frame: 1 day
description: Identifying clinical risk factors (Odds Ratio), using the binary logistic regression method, significantly associated with a positive Paracetamol DPT.
Age at reaction, sex, presence of asthma and atopy, type and chronology of the initial reaction will be evaluated as potential risk factors. Risk factors of anaphylaxis during DPT will also be calculated, using the same variables.
Potential variables to explain this measure will be introduced in a logistic model, in order to obtain crude and adjusted OR that could explain a positive DPT to paracetamol.
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: Hypersensitivity
mesh term: Drug Hypersensitivity
sharing ipd: No