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/NCT05971901</url>
    </required_header>
    <id_info>
      <org_study_id>233/22</org_study_id>
      <nct_id>NCT05971901</nct_id>
    </id_info>
    <brief_title>A Combinatorial Biomarker for Infection Diagnosis in Children</brief_title>
    <acronym>CROCODILE-I</acronym>
    <official_title>A Combinatorial Biomarker for Infection Diagnosis in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universität des Saarlandes</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universität des Saarlandes</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>
        To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment&#xD;
        outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and&#xD;
        CRP) is used, and to compare them with control patients without BV measurement.&#xD;
  &#xD;
        Secondary objectives:&#xD;
  &#xD;
          -  Qualitative evaluation of indication as well as adherence to the test result.&#xD;
  &#xD;
          -  Comparison of antimicrobial therapy, performed diagnostics, hospitalization, and&#xD;
             outcomes between patients with high BV score (bacterial) and patients with low BV score&#xD;
             (viral).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 24, 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Antibiotics</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Number of participants treated with antibiotics</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Antibiotic duration</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Length of antibiotic treatment per participant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Number of participants admitted to the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Rate of complications per participant</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tests</measure>
      <time_frame>up to 30 days</time_frame>
      <description>Rate of ancillary tests per participant</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">770</enrollment>
    <condition>Respiratory Tract Infections</condition>
    <condition>Fever</condition>
    <arm_group>
      <arm_group_label>BV use cases</arm_group_label>
      <description>cases in whom BV was ordered</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BV non-use cases</arm_group_label>
      <description>cases in whom BV was not ordered</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>BV</intervention_name>
      <description>The use of the BV test, ordered at the discretion of the treating physician</description>
      <arm_group_label>BV use cases</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients for whom the treating physicians request the determination of the BV score from&#xD;
          the patient's serum due to a suspected infection can be included in this study, provided&#xD;
          that they meet the above inclusion criteria, are capable of giving consent and agree to&#xD;
          participate in the study (or, in the case of incapacitated patients, written consent is&#xD;
          obtained from their legal guardian, health care proxy or custodian).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Suspicion of acute bacterial or viral infection&#xD;
  &#xD;
            -  Requirement of at least one BV test during medical presentation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  lack of informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Months</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cihan Papan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universität des Saarlandes</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cihan Papan, MD</last_name>
      <phone>+4968411623900</phone>
      <email>cihan.papan@uni-saarland.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Soeren Becker, MD, PhD</last_name>
      <phone>+4968411623901</phone>
      <email>soeren.becker@uks.eu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sana Kliniken</name>
        <address>
          <city>Berlin</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Tobias Tenenbaum, MD</last_name>
        <phone>00493055185131</phone>
        <email>Tobias.Tenenbaum@Sana.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Bonn</name>
        <address>
          <city>Bonn</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Cihan Papan, MD</last_name>
        <phone>004922828714639</phone>
        <email>cihan.papan@ukbonn.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Saarland University</name>
        <address>
          <city>Homburg</city>
          <zip>66421</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cihan Papan, MD</last_name>
        <phone>004968411623900</phone>
        <email>cihan.papan@uni-saarland.de</email>
      </contact>
      <contact_backup>
        <last_name>Soeren Becker, MD, PhD</last_name>
        <phone>004968411623900</phone>
        <email>soeren.becker@uks.eu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Würzburg</name>
        <address>
          <city>Würzburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Johannes Liese, MD</last_name>
        <phone>004993120127725</phone>
        <email>Liese_J@ukw.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universität des Saarlandes</investigator_affiliation>
      <investigator_full_name>Cihan Papan</investigator_full_name>
      <investigator_title>Principial Investigator</investigator_title>
    </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>Respiratory Tract Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05971901
  org study id: 233/22
  nct id: NCT05971901
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To describe the epidemiology, clinical presentation, diagnosis, therapy, and treatment
        outcomes of patients in whom the combination biomarker BV (combination of TRAIL, IP-10, and
        CRP) is used, and to compare them with control patients without BV measurement.
  
        Secondary objectives:
  
          -  Qualitative evaluation of indication as well as adherence to the test result.
  
          -  Comparison of antimicrobial therapy, performed diagnostics, hospitalization, and
             outcomes between patients with high BV score (bacterial) and patients with low BV score
             (viral).
  observational model: Cohort
  time perspective: Prospective
  measure: Antibiotics
  time frame: up to 30 days
  description: Number of participants treated with antibiotics
  measure: Antibiotic duration
  time frame: up to 30 days
  description: Length of antibiotic treatment per participant
  measure: Hospitalization
  time frame: up to 30 days
  description: Number of participants admitted to the hospital
  measure: Complications
  time frame: up to 30 days
  description: Rate of complications per participant
  measure: Tests
  time frame: up to 30 days
  description: Rate of ancillary tests per participant
  arm group label: BV use cases
  description: cases in whom BV was ordered
  arm group label: BV non-use cases
  description: cases in whom BV was not ordered
  intervention type: Diagnostic Test
  intervention name: BV
  description: The use of the BV test, ordered at the discretion of the treating physician
  arm group label: BV use cases
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Months
  maximum age: N/A
  healthy volunteers: No
  last name: Cihan Papan, MD
  role: Principal Investigator
  affiliation: Universität des Saarlandes
  last name: Cihan Papan, MD
  phone: +4968411623900
  email: cihan.papan@uni-saarland.de
  last name: Soeren Becker, MD, PhD
  phone: +4968411623901
  email: soeren.becker@uks.eu
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: Universität des Saarlandes
  investigator full name: Cihan Papan
  investigator title: Principial Investigator
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Respiratory Tract Infections
  sharing ipd: Undecided