<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/NCT04421638</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0021</org_study_id>
    <nct_id>NCT04421638</nct_id>
  </id_info>
  <brief_title>Cephalosporin Hypersensitivity</brief_title>
  <acronym>CephALL</acronym>
  <official_title>Drug Hypersensitivity Reactions To Cephalosporins</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 :&#xD;
&#xD;
      Although the hypersensitivity reactions to cephalosporins have been recently a more focused&#xD;
      subject, studies on the cephalosporin as an allergen are significantly less frequent that&#xD;
      those regarding penicillins. Most of the available data regards cephalosporin sensitization&#xD;
      in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one&#xD;
      of the most prescribed classes of antibiotics. The diagnosis of cephalosporin&#xD;
      hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation&#xD;
      tests (DPT). This succession of tests, performed in specialized services, allows to eliminate&#xD;
      responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to&#xD;
      identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.&#xD;
&#xD;
      Objective: To analyse the characteristics of patients studied in our Unit for suspicion of&#xD;
      cephalosporin hypersensitivity.&#xD;
&#xD;
      Methods: This retrospective study will comprise all the patients who attended the allergy&#xD;
      service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of&#xD;
      cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up and&#xD;
      who gave their consent to be included in the study . The Patients are selected from the Drug&#xD;
      Allergy &amp; Hypersensitivity Database (DAHD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2020</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</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>Identify clinical variables associated with allergy to cephalosporins</measure>
    <time_frame>1 day</time_frame>
    <description>Identify clinical variables associated with allergy to cephalosporins</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the risk variables associated with allergy to cephalosporins</measure>
    <time_frame>1 day</time_frame>
    <description>Determine the risk variables associated with allergy to cephalosporins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To calculate the negative predictive value of cephalosporin DTP</measure>
    <time_frame>1 years</time_frame>
    <description>In the subgroup of patients for whom we have data on readministration of a negatively tested cephalosporin following drug allergy work-up, we will calculate the negative predictive value of cephalosporin DPT.</description>
  </secondary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Drug Hypersensitivity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient consulting in our allergy unit for a suspicion of DHR to cephalosporins and who&#xD;
        underwent a drug allergy work-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Patients with one or more ST and DPT tests to cephalosporins&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - Patients refusing to take part in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anca Chiriac, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 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>Cephalosporins</keyword>
  <keyword>Betalactams</keyword>
  <keyword>Risk Factor</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>Undecided</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/NCT04421638
org study id: RECHMPL20_0021
nct id: NCT04421638
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background :

      Although the hypersensitivity reactions to cephalosporins have been recently a more focused
      subject, studies on the cephalosporin as an allergen are significantly less frequent that
      those regarding penicillins. Most of the available data regards cephalosporin sensitization
      in patients previously allergic to penicillin. Like penicillins, cephalosporins represent one
      of the most prescribed classes of antibiotics. The diagnosis of cephalosporin
      hypersensitivity is based mainly on clinical history, skin tests (ST) and drug provocation
      tests (DPT). This succession of tests, performed in specialized services, allows to eliminate
      responsibility for the drug in many cases (80-85%). The drug allergy work-up also allows to
      identify profiles of allergy to cephalosporins, with different patterns of cross-reactivity.

      Objective: To analyse the characteristics of patients studied in our Unit for suspicion of
      cephalosporin hypersensitivity.

      Methods: This retrospective study will comprise all the patients who attended the allergy
      service of the UH of Montpellier from 1997 till 2018 with a clinical history evocative of
      cephalosporin drug hypersensitivity reaction (DHR), who underwent a drug allergy work up 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: Identify clinical variables associated with allergy to cephalosporins
time frame: 1 day
description: Identify clinical variables associated with allergy to cephalosporins
measure: Determine the risk variables associated with allergy to cephalosporins
time frame: 1 day
description: Determine the risk variables associated with allergy to cephalosporins
measure: To calculate the negative predictive value of cephalosporin DTP
time frame: 1 years
description: In the subgroup of patients for whom we have data on readministration of a negatively tested cephalosporin following drug allergy work-up, we will calculate the negative predictive value of cephalosporin DPT.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Anca Chiriac, 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: Undecided