<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/NCT02972281</url>
  </required_header>
  <id_info>
    <org_study_id>2014_07</org_study_id>
    <secondary_id>2014-A00739-38</secondary_id>
    <nct_id>NCT02972281</nct_id>
  </id_info>
  <brief_title>Systematic Search for Primary Immunodeficiency in Adults With Infections</brief_title>
  <acronym>SPIDAC</acronym>
  <official_title>Systematic Search for Primary Immunodeficiency in Adults With Unexplained Recurrent and/or Severe Infections With Encapsulated Bacteria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Imagine Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Octapharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>CSL Behring</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laboratoire français de Fractionnement et de Biotechnologies</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Air Liquide SA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Binding Site Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Antibody deficiencies and complement deficiencies are the most frequent Primary&#xD;
      immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility&#xD;
      to recurrent and/or severe bacterial infections - especially upper and lower respiratory&#xD;
      tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in&#xD;
      adults. The current European and US guidelines advocate screening adults for PIDs if they&#xD;
      present recurrent benign especially upper and lower respiratory tract infections, or if they&#xD;
      have experienced at least two severe bacterial infections and/or have a recurrent need for&#xD;
      intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in&#xD;
      adult patients who present such recurrent infections and/or after the first severe bacterial&#xD;
      infection, especially when the patients do not present with known, etiologically relevant&#xD;
      comorbidities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    deficient inclusions&#xD;
  </why_stopped>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria</measure>
    <time_frame>At 6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Complement Deficiency</condition>
  <condition>Antibody Deficiency</condition>
  <condition>Chronic Sinus Infection</condition>
  <condition>Meningitis, Bacterial</condition>
  <condition>Pneumonia, Bacterial</condition>
  <condition>Otitis Media</condition>
  <condition>Streptococcal Infection</condition>
  <condition>Neisseria Infections</condition>
  <condition>Haemophilus Influenza</condition>
  <condition>Pneumococcal Infections</condition>
  <arm_group>
    <arm_group_label>Patients with bacterial infections</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with recurrent and/or severe bacterial infections</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Immunological diagnosis tests</intervention_name>
    <description>(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...</description>
    <arm_group_label>Patients with bacterial infections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 yrs old patients&#xD;
&#xD;
          -  ≥ 2 bacterial upper or lower respiratory tract infections/years, for at least 2 years,&#xD;
             or&#xD;
&#xD;
          -  ≥ 1 severe bacterial upper or lower respiratory tract infection requiring&#xD;
             hospitalization and IV antibiotics, or&#xD;
&#xD;
          -  ≥ 1 invasive infection (meningitis, bacteriemia, arthritis) due to Streptococcus&#xD;
             pneumoniae, group A Streptococcus, Haemophilus influenzae, Neisseria meningitidis or&#xD;
             Neisseria gonorrhoeae&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concomitant, systemic comorbidity that predisposes to infection (solid or&#xD;
             hematological cancer, diabetes mellitus, severe alcohol or intravenous drug abuse,&#xD;
             chronic liver or kidney failure, human immunodeficiency virus infection, anatomic or&#xD;
             functional asplenia, drug-induced 1 neutropenia, or solid organ or hematopoietic stem&#xD;
             cell transplantation).&#xD;
&#xD;
          -  the presence of a local predisposing factor: cigarette smoking (&gt; 5 pack-year and/or 5&#xD;
             cigarettes/day), underlying infection (tuberculosis, influenza…), chronic obstructive&#xD;
             pulmonary disease, cystic fibrosis or bronchiectasis for pulmonary infections;&#xD;
             cerebrospinal leak or preceding upper respiratory tract (URT) infections for&#xD;
             non-meningococcal meningitis; oral, dental or skin condition for GAS infections&#xD;
&#xD;
          -  use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressants or&#xD;
             cytotoxic chemotherapeutics&#xD;
&#xD;
          -  PID diagnosed before the infectious episode in question.&#xD;
&#xD;
          -  current or recent pregnancy&#xD;
&#xD;
          -  hospital-acquired infection (including infections of prostheses).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume Lefevre, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ch Armentieres</name>
      <address>
        <city>Armentières</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH ARRAS</name>
      <address>
        <city>Arras</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Boulogne-Sur-Mer</name>
      <address>
        <city>Boulogne Sur Mer</city>
        <zip>62321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Bethune</name>
      <address>
        <city>Béthune</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Cambrai</name>
      <address>
        <city>Cambrai</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Denain</name>
      <address>
        <city>Denain</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH DOUAI</name>
      <address>
        <city>Douai</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Dunkerque</name>
      <address>
        <city>Dunkerque</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH LENS</name>
      <address>
        <city>Lens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Prive La Louviere</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU,</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Vincent - Saint Antoine</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Arrondissement de Montreuil</name>
      <address>
        <city>Rang-du-Fliers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H de Roubaix</name>
      <address>
        <city>Roubaix</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Region de St-Omer</name>
      <address>
        <city>Saint-Omer</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Seclin Carvin</name>
      <address>
        <city>Seclin</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch Tourcoing</name>
      <address>
        <city>Tourcoing</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ch de Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Teissier</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Pneumococcal Infections</mesh_term>
    <mesh_term>Streptococcal Infections</mesh_term>
    <mesh_term>Pneumonia, Bacterial</mesh_term>
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Meningitis, Bacterial</mesh_term>
    <mesh_term>Otitis Media</mesh_term>
    <mesh_term>Meningitis</mesh_term>
    <mesh_term>Primary Immunodeficiency Diseases</mesh_term>
    <mesh_term>Hereditary Complement Deficiency Diseases</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/NCT02972281
org study id: 2014_07
secondary id: 2014-A00739-38
nct id: NCT02972281
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Antibody deficiencies and complement deficiencies are the most frequent Primary
      immunodeficiencies (PIDs) in adults, and are associated with greatly increased susceptibility
      to recurrent and/or severe bacterial infections - especially upper and lower respiratory
      tract infections and meningitis. The literature data suggest that PIDs are under-diagnosed in
      adults. The current European and US guidelines advocate screening adults for PIDs if they
      present recurrent benign especially upper and lower respiratory tract infections, or if they
      have experienced at least two severe bacterial infections and/or have a recurrent need for
      intravenous antibiotics. The objective of the demonstrate the interest of PIDs screening in
      adult patients who present such recurrent infections and/or after the first severe bacterial
      infection, especially when the patients do not present with known, etiologically relevant
      comorbidities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Frequency of Primary immunodeficiencies (PIDs) in adult patients with recurrent and/or severe bacterial infection with encapsulated bacteria
time frame: At 6 months
arm group label: Patients with bacterial infections
arm group type: Other
description: Patients with recurrent and/or severe bacterial infections
intervention type: Biological
intervention name: Immunological diagnosis tests
description: (Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...
arm group label: Patients with bacterial infections
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Guillaume Lefevre, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
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country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pneumococcal Infections
mesh term: Streptococcal Infections
mesh term: Pneumonia, Bacterial
mesh term: Sinusitis
mesh term: Meningitis, Bacterial
mesh term: Otitis Media
mesh term: Meningitis
mesh term: Primary Immunodeficiency Diseases
mesh term: Hereditary Complement Deficiency Diseases
sharing ipd: Undecided