<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/NCT02207647</url>
  </required_header>
  <id_info>
    <org_study_id>12H-770352</org_study_id>
    <secondary_id>U01CK000176</secondary_id>
    <nct_id>NCT02207647</nct_id>
  </id_info>
  <brief_title>Prevalence of Pathogens in Cerebrospinal Fluid Obtained From Emergency Department Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olive View-UCLA Education &amp; Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Olive View-UCLA Education &amp; Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a&#xD;
      potentially infectious nature are among those of greatest concern. Routine clinical and&#xD;
      laboratory evaluation of such patients involves screening for known infectious disease&#xD;
      agents, selection of which is nonstandardized. Progress in diagnostic technologies,&#xD;
      especially molecular techniques based on genetic characteristics of potential pathogens, has&#xD;
      greatly expanded the investigators capacity to evaluate specimens from patients for a much&#xD;
      wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of&#xD;
      Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative&#xD;
      agents for the approximately 50% of all such presentations which go un-diagnosed. The&#xD;
      investigators propose a study involving a collaboration between the EMERGEncy ID NET, a&#xD;
      network of 10 geographically diverse university-affiliated urban emergency departments&#xD;
      (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and&#xD;
      Prevention (CDC), to use these new technologies to address this issue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding used up&#xD;
  </why_stopped>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prevalence of pathogens</measure>
    <time_frame>2 years</time_frame>
    <description>We will describe the range and proportion of pathogens found in CSF among patients enrolled over a 2 year period.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Meningoencephalitis</condition>
  <condition>Other Syndromes Requiring Lumbar Puncture in Emergency Department</condition>
  <arm_group>
    <arm_group_label>Patients with syndromes requiring lumbar puncture</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <arm_group_label>Patients with syndromes requiring lumbar puncture</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cerebrospinal fluid and blood serum are being collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will be conducted by the Emergency ID Net Study group (P.I. David Talan), which&#xD;
        consists of a network of 10 emergency departments in university-affiliated hospitals&#xD;
        throughout the United States.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; or = 3 months old&#xD;
&#xD;
          -  Receiving a Lumbar Puncture in the emergency department as part of their standard&#xD;
             care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No CSF available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Olive View-UCLA Medical Center</name>
      <address>
        <city>Sylmar</city>
        <state>California</state>
        <zip>91342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Olive View-UCLA Education &amp; Research Institute</investigator_affiliation>
    <investigator_full_name>David A. Talan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meningoencephalitis</mesh_term>
    <mesh_term>Emergencies</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/NCT02207647
org study id: 12H-770352
secondary id: U01CK000176
nct id: NCT02207647
lead sponsor: 
collaborator: 
has dmc: No
Of all emergency room patients, persons presenting with encephalitis/meningitis syndrome of a
      potentially infectious nature are among those of greatest concern. Routine clinical and
      laboratory evaluation of such patients involves screening for known infectious disease
      agents, selection of which is nonstandardized. Progress in diagnostic technologies,
      especially molecular techniques based on genetic characteristics of potential pathogens, has
      greatly expanded the investigators capacity to evaluate specimens from patients for a much
      wider range of potential pathogens (bacterial, viral, fungal and parasitic agents). Use of
      Polymerase Chain Reaction (PCR) technology offers the possibility of identifying causative
      agents for the approximately 50% of all such presentations which go un-diagnosed. The
      investigators propose a study involving a collaboration between the EMERGEncy ID NET, a
      network of 10 geographically diverse university-affiliated urban emergency departments
      (coordinated by Olive View-UCLA Medical Center) and the Centers for Disease Control and
      Prevention (CDC), to use these new technologies to address this issue.
observational model: Ecologic or Community
time perspective: Prospective
measure: prevalence of pathogens
time frame: 2 years
description: We will describe the range and proportion of pathogens found in CSF among patients enrolled over a 2 year period.
arm group label: Patients with syndromes requiring lumbar puncture
intervention type: Other
intervention name: no intervention
arm group label: Patients with syndromes requiring lumbar puncture
Cerebrospinal fluid and blood serum are being collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Olive View-UCLA Education & Research Institute
investigator full name: David A. Talan
investigator title: Principal Investigator
mesh term: Meningoencephalitis
mesh term: Emergencies