<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/NCT03798704</url>
  </required_header>
  <id_info>
    <org_study_id>Arnez 0120-134/2018</org_study_id>
    <nct_id>NCT03798704</nct_id>
  </id_info>
  <brief_title>Comparison of IFA and LIAISON® for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years</brief_title>
  <official_title>Comparison of Immunofluorescence Assay (IFA) and Chemiluminiscence Immunoassay (LIAISON®) for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Ljubljana</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>
      The aim of this study is to compare two different serological tests, IFA and LIAISON, for&#xD;
      detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early&#xD;
      disseminated Lyme borreliosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick - borne multisystem&#xD;
      infectious disease caused by Borrelia burgdorferi sensu lato.&#xD;
&#xD;
      Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and&#xD;
      microbiological confirmation of borrelial infection is not required for diagnosis.&#xD;
&#xD;
      Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral&#xD;
      facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis,&#xD;
      indicating the need for laboratory demonstration of borrelial infection which is mainly&#xD;
      accomplished with serological tests.&#xD;
&#xD;
      For detection of borrelial antibodies several methods are used, such as immunofluorescent&#xD;
      assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized&#xD;
      and have limited sensitivity and specificity.&#xD;
&#xD;
      The aim of this study is to specify and compare the sensitivity of IFA and LIAISON&#xD;
      serological tests in early disseminated LB in children in Slovenia.&#xD;
&#xD;
      The secondary aim is to determine the influence of early antibiotic treatment of early&#xD;
      disseminated LB on serological results in children with LB in Slovenia and to compare the&#xD;
      serological results in children who are treated with antibiotics immediately and those who&#xD;
      are treated later in the course of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Sensitivity IFA vs. LIAISON</measure>
    <time_frame>2 years</time_frame>
    <description>LIAISON test (E/ml) is expected to be more sensitive than IFA (titer) in detection of Borrelial antibodies in children with early disseminated LB. In all patients both asseys (LIAISON and IFA) are going to be done from the same samples. The difference in the proportion of positive tests between the two assays will be statisticaly analyzed for IgM and IgG antibodies of each patient group. P values &lt; 0,05 will be interpreted as statistically significant.&#xD;
IFA: Titres &gt;256 in serum and &gt;4 in CSF will be considered positive. LIAISON values in serum: the values of IgM and IgG in serum &lt;18 in &lt;10 E/ml will be considered as negative, 18-22 and 10-15 E/ml will be considerd as border values and &gt;22 in &gt;15 E/ml will be considered as positive.&#xD;
LIAISON in cerebral fluid: the values of IgM in IgG in cerebral fluid &lt;2,5 and &lt;4,5 E/ml will be considered as negative, values 2,5-3,5 and 4,5-5,5 E/ml will be considered as border values and &gt;2,5 in &gt;5,5 E/ml will be considered as positive.</description>
  </primary_outcome>
  <enrollment type="Actual">349</enrollment>
  <condition>Lyme Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IFA, LIAISON</intervention_name>
    <description>Comparison of two diagnostic serological tests - IFA and LIAISON.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Younger then 18 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Children younger than 18 years with early disseminated Lyme disease:&#xD;
&#xD;
          -  multiple erythema migrans&#xD;
&#xD;
          -  peripheral facial nerve palsy&#xD;
&#xD;
          -  lymphocytic meningitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University clinical center</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Maja Arnez</investigator_full_name>
    <investigator_title>izr. prof. dr. Maja Arnez, dr. med</investigator_title>
  </responsible_party>
  <keyword>Lyme disease</keyword>
  <keyword>IFA</keyword>
  <keyword>LIAISON</keyword>
  <keyword>children</keyword>
  <keyword>Slovenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lyme Disease</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/NCT03798704
org study id: Arnez 0120-134/2018
nct id: NCT03798704
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare two different serological tests, IFA and LIAISON, for
      detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early
      disseminated Lyme borreliosis.
Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick - borne multisystem
      infectious disease caused by Borrelia burgdorferi sensu lato.

      Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and
      microbiological confirmation of borrelial infection is not required for diagnosis.

      Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral
      facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis,
      indicating the need for laboratory demonstration of borrelial infection which is mainly
      accomplished with serological tests.

      For detection of borrelial antibodies several methods are used, such as immunofluorescent
      assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized
      and have limited sensitivity and specificity.

      The aim of this study is to specify and compare the sensitivity of IFA and LIAISON
      serological tests in early disseminated LB in children in Slovenia.

      The secondary aim is to determine the influence of early antibiotic treatment of early
      disseminated LB on serological results in children with LB in Slovenia and to compare the
      serological results in children who are treated with antibiotics immediately and those who
      are treated later in the course of the study.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity IFA vs. LIAISON
time frame: 2 years
description: LIAISON test (E/ml) is expected to be more sensitive than IFA (titer) in detection of Borrelial antibodies in children with early disseminated LB. In all patients both asseys (LIAISON and IFA) are going to be done from the same samples. The difference in the proportion of positive tests between the two assays will be statisticaly analyzed for IgM and IgG antibodies of each patient group. P values < 0,05 will be interpreted as statistically significant.
IFA: Titres >256 in serum and >4 in CSF will be considered positive. LIAISON values in serum: the values of IgM and IgG in serum <18 in <10 E/ml will be considered as negative, 18-22 and 10-15 E/ml will be considerd as border values and >22 in >15 E/ml will be considered as positive.
LIAISON in cerebral fluid: the values of IgM in IgG in cerebral fluid <2,5 and <4,5 E/ml will be considered as negative, values 2,5-3,5 and 4,5-5,5 E/ml will be considered as border values and >2,5 in >5,5 E/ml will be considered as positive.
intervention type: Diagnostic Test
intervention name: IFA, LIAISON
description: Comparison of two diagnostic serological tests - IFA and LIAISON.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Maja Arnez
investigator title: izr. prof. dr. Maja Arnez, dr. med
mesh term: Lyme Disease
sharing ipd: Undecided