xml: <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/NCT05981599</url>
    </required_header>
    <id_info>
      <org_study_id>CARACIIM</org_study_id>
      <nct_id>NCT05981599</nct_id>
    </id_info>
    <brief_title>Epidemiological, Clinical and Biological Caracteristics of Patients Presenting With Invasive Meningococcal Disease</brief_title>
    <acronym>CARACIIM</acronym>
    <official_title>Epidemiological, Clinical and Biological Caracteristics of Patients Presenting With Invasive Meningococcal Disease in the West of France</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Poitiers University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Poitiers University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        An unusual increase in cases of invasive meningococcal infection between late 2022 and early&#xD;
        2023. These cases sometimes had atypical presentations (large numbers of bacteremias without&#xD;
        meningitis). The distribution of serogroups was also unusual in our center (large number of&#xD;
        serotype Y meningococcal IMD).&#xD;
  &#xD;
        This development comes after three years marked by the Corona-Virus-Disease-19 pandemic,&#xD;
        which led to a profound change in the behaviors involved in the transmission of infectious&#xD;
        diseases. Barrier measures have considerably reduced the population's exposure to&#xD;
        meningococcus, and may have encouraged a reduction in mucosal immunity to this pathogen. The&#xD;
        end of 2022 was also marked by intense viral circulation (syncitial respiratory&#xD;
        virus-influenza-COVID), which may have favored invasive forms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Invasive meningococcal disease (IMD) accounts for a small number of cases (500-600&#xD;
        cases/year) in mainland France. Despite advances in its management, the disease is still&#xD;
        associated with a 10-20% mortality rate and impaired quality of life in 50% of surviving&#xD;
        patients.&#xD;
  &#xD;
        An unusual increase in cases of invasive meningococcal infection during the winter of 2022.&#xD;
        These cases often had atypical presentations (large number of bacteremias without meningitis,&#xD;
        digestive picture in the foreground). The distribution of serogroups was also unusual at our&#xD;
        center (large number of serotype Y meningococcal IMD). These data appear to be confirmed by&#xD;
        Santé Publique France's national data for 2022, with no warning of the spread of a&#xD;
        hyper-virulent clone.&#xD;
  &#xD;
        This development comes after three years marked by the SARS-CoV2 pandemic, which led to a&#xD;
        profound change in the behaviors involved in the transmission of infectious diseases .&#xD;
  &#xD;
        Barrier measures have considerably reduced the population's exposure to meningococcus, and&#xD;
        may have led to a reduction in mucosal immunity to this pathogen. This is particularly true&#xD;
        of teenagers and young adults, for whom contact has fallen sharply due to the closure of&#xD;
        schools and universities. It would be interesting to see whether this population is more&#xD;
        affected this year than in previous years.&#xD;
  &#xD;
        The end of 2022 was also marked by intense viral circulation (SRV-Flu-Covid), which could&#xD;
        have favored invasive forms. Evidence of a significant number of viral co-infections could&#xD;
        support this hypothesis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>Number of patient presenting with Invasive Meningococcal infection and its serogroup</measure>
      <time_frame>Two period of 18month, one when facial mask were recommanded, and one after</time_frame>
      <description>- Evolution of the Number of case according to time and the evolution of serogroup There will be two study period. The number of Invasive Meningococcal infection and their serogroup will be counted in each period.</description>
    </primary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Meningococcal Infections</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>There is no intervention</intervention_name>
      <description>There is no intervention. Only retrieving clinical, biological and epidemiological data from patient files</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient from the West part of France&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Clinical diagnosis of Invasive Meningococcal infection (defined by the isolation of&#xD;
          Neisseria meningitis in a normaly steril site (CSL, blood, articulation, ..) by PCR or&#xD;
          culture.&#xD;
  &#xD;
          No exclusion Criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>France CAZENAVE ROBLOT, PhD</last_name>
      <role>Study Director</role>
      <affiliation>SPILF</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Romain Millot, Resident</last_name>
      <phone>+33643002422</phone>
      <email>romain.millot@chu-poitiers.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>France CAZENAVE ROBLOT, PhD</last_name>
      <phone>+33549445454</phone>
      <email>france.cazenave-roblot@chu-poitiers.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Poitiers University</name>
        <address>
          <city>Poitiers</city>
          <state>Vienne</state>
          <zip>86000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>France Cazenave Roblot, PhD</last_name>
        <phone>+33549445454</phone>
        <email>france.cazenave-roblot@chu-poitiers.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</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>Meningococcal Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <study_docs>
      <study_doc>
        <doc_type>Actuality report</doc_type>
        <doc_url>https://www.santepubliquefrance.fr/content/download/504135/3759948?version=2</doc_url>
        <doc_comment>French Report on the epidemic situation of meningococcal disease in december 2022</doc_comment>
      </study_doc>
      <study_doc>
        <doc_type>Clinical Study Report</doc_type>
        <doc_url>https://doi.org/10.1371/journal.pone.0281544</doc_url>
      </study_doc>
    </study_docs>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981599
  org study id: CARACIIM
  nct id: NCT05981599
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  An unusual increase in cases of invasive meningococcal infection between late 2022 and early
        2023. These cases sometimes had atypical presentations (large numbers of bacteremias without
        meningitis). The distribution of serogroups was also unusual in our center (large number of
        serotype Y meningococcal IMD).
  
        This development comes after three years marked by the Corona-Virus-Disease-19 pandemic,
        which led to a profound change in the behaviors involved in the transmission of infectious
        diseases. Barrier measures have considerably reduced the population's exposure to
        meningococcus, and may have encouraged a reduction in mucosal immunity to this pathogen. The
        end of 2022 was also marked by intense viral circulation (syncitial respiratory
        virus-influenza-COVID), which may have favored invasive forms.
  Invasive meningococcal disease (IMD) accounts for a small number of cases (500-600
        cases/year) in mainland France. Despite advances in its management, the disease is still
        associated with a 10-20% mortality rate and impaired quality of life in 50% of surviving
        patients.
  
        An unusual increase in cases of invasive meningococcal infection during the winter of 2022.
        These cases often had atypical presentations (large number of bacteremias without meningitis,
        digestive picture in the foreground). The distribution of serogroups was also unusual at our
        center (large number of serotype Y meningococcal IMD). These data appear to be confirmed by
        Santé Publique France's national data for 2022, with no warning of the spread of a
        hyper-virulent clone.
  
        This development comes after three years marked by the SARS-CoV2 pandemic, which led to a
        profound change in the behaviors involved in the transmission of infectious diseases .
  
        Barrier measures have considerably reduced the population's exposure to meningococcus, and
        may have led to a reduction in mucosal immunity to this pathogen. This is particularly true
        of teenagers and young adults, for whom contact has fallen sharply due to the closure of
        schools and universities. It would be interesting to see whether this population is more
        affected this year than in previous years.
  
        The end of 2022 was also marked by intense viral circulation (SRV-Flu-Covid), which could
        have favored invasive forms. Evidence of a significant number of viral co-infections could
        support this hypothesis.
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of patient presenting with Invasive Meningococcal infection and its serogroup
  time frame: Two period of 18month, one when facial mask were recommanded, and one after
  description: - Evolution of the Number of case according to time and the evolution of serogroup There will be two study period. The number of Invasive Meningococcal infection and their serogroup will be counted in each period.
  intervention type: Other
  intervention name: There is no intervention
  description: There is no intervention. Only retrieving clinical, biological and epidemiological data from patient files
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: France CAZENAVE ROBLOT, PhD
  role: Study Director
  affiliation: SPILF
  last name: Romain Millot, Resident
  phone: +33643002422
  email: romain.millot@chu-poitiers.fr
  last name: France CAZENAVE ROBLOT, PhD
  phone: +33549445454
  email: france.cazenave-roblot@chu-poitiers.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Meningococcal Infections
  sharing ipd: Undecided
  study doc: 
  study doc: 