<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/NCT01694524</url>
  </required_header>
  <id_info>
    <org_study_id>febrile seizure and infection</org_study_id>
    <nct_id>NCT01694524</nct_id>
  </id_info>
  <brief_title>Nervous System Infections Among Patients With Febrile Seizure</brief_title>
  <official_title>Nervous System Infections Among Patients With Febrile Seizure : Retrospective Cohort Review of Consecutive Patients Admitted in 7 Pediatric Emergency Departments in Ile-de-France Between 2007 and 2011</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Armand Trousseau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hopital Universitaire Robert-Debre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Jean Verdier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Versailles Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre hospitalier Lagny Marne la vallée</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre hospitalier intercommunal de Poissy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hôpital Armand Trousseau</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Few studies dealing with the risk of infectious of nervous system and the utility of lumbar&#xD;
      puncture and of emergent neuroimaging among patients with simple febrile seizure between 3&#xD;
      and 11 months age and with complex seizure has been reported. None of these studies was&#xD;
      multicentric. Recommendations about management of these children are heterogeneous.&#xD;
&#xD;
      The investigators aim to study by an observational retrospective multicentric study the rate&#xD;
      of infectious of central nervous system among patients with a complex febrile seizure and&#xD;
      among patients between 3 and 11 months age with simple febrile seizure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Bacterial meningitis</measure>
    <time_frame>7 days after emergency visit</time_frame>
    <description>Results of lumbar puncture or meningitis history in charts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Herpes simplex virus meningitis/encephalitis</measure>
    <time_frame>7 days after emergency visit</time_frame>
    <description>Results of lumbar puncture or meningitis history in charts</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>emergent intracranial processus</measure>
    <time_frame>7 days after emergency visit</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1200</enrollment>
  <condition>Seizure</condition>
  <condition>Febrile Seizure</condition>
  <condition>Meningitis</condition>
  <condition>Encephalitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This was a retrospective cohort review of consecutive patients admitted in 7 pediatric&#xD;
        emergency departments in Ile-de-France between 2007 and 2011. All clinically well-apparent&#xD;
        children 3 to 11 months of age with a first simple febrile seizure were included in the&#xD;
        study. All children between 3 months and 5 years with a complex febrile seizure were&#xD;
        included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  febrile (&gt;38°)&#xD;
&#xD;
          -  Seizure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous non febrile seizure&#xD;
&#xD;
          -  known trauma&#xD;
&#xD;
          -  immunodeficiancy status&#xD;
&#xD;
          -  Underlying illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Carbajal, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Armand Trousseau, Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Jean Verdier</name>
      <address>
        <city>Bondy</city>
        <zip>93140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier intercommunal de creteil</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Lagny-Marne la Vallée</name>
      <address>
        <city>Lagny-Sur-Marne</city>
        <zip>77405</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de Versailles</name>
      <address>
        <city>Le chesnay</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Armand Trousseau</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Robert Debré</name>
      <address>
        <city>Paris</city>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier intercommunal de Poissy</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>May 19, 2014</last_update_submitted>
  <last_update_submitted_qc>May 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Armand Trousseau</investigator_affiliation>
    <investigator_full_name>CARBAJAL</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Meningitis</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Seizures, Febrile</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <!-- 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/NCT01694524
org study id: febrile seizure and infection
nct id: NCT01694524
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Few studies dealing with the risk of infectious of nervous system and the utility of lumbar
      puncture and of emergent neuroimaging among patients with simple febrile seizure between 3
      and 11 months age and with complex seizure has been reported. None of these studies was
      multicentric. Recommendations about management of these children are heterogeneous.

      The investigators aim to study by an observational retrospective multicentric study the rate
      of infectious of central nervous system among patients with a complex febrile seizure and
      among patients between 3 and 11 months age with simple febrile seizure.
observational model: Cohort
time perspective: Retrospective
measure: Bacterial meningitis
time frame: 7 days after emergency visit
description: Results of lumbar puncture or meningitis history in charts
measure: Herpes simplex virus meningitis/encephalitis
time frame: 7 days after emergency visit
description: Results of lumbar puncture or meningitis history in charts
measure: emergent intracranial processus
time frame: 7 days after emergency visit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 5 Years
healthy volunteers: No
last name: Ricardo Carbajal, MD, PhD
role: Principal Investigator
affiliation: Hôpital Armand Trousseau, Paris
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital Armand Trousseau
investigator full name: CARBAJAL
investigator title: Professor
mesh term: Seizures
mesh term: Meningitis
mesh term: Encephalitis
mesh term: Seizures, Febrile
mesh term: Hyperthermia
mesh term: Fever