<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/NCT03011515</url>
  </required_header>
  <id_info>
    <org_study_id>MM-1005-OB</org_study_id>
    <nct_id>NCT03011515</nct_id>
  </id_info>
  <brief_title>Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)</brief_title>
  <acronym>OBSERVER</acronym>
  <official_title>A Multi-center, Prospective, Validation Study to Assess the Accuracy of a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Adult Patients With Lower Respiratory Tract Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MeMed Diagnostics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carmel Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Commission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MeMed Diagnostics Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to validate the diagnostic accuracy of a novel host-response&#xD;
      based diagnostic tool for differentiating between bacterial and viral etiologies in adult&#xD;
      patients aged 18 years and older with clinical suspicion of lower respiratory tract&#xD;
      infections (LRTI)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">January 7, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI</measure>
    <time_frame>0-6 days after the initiation of symptoms</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To compare the diagnostic accuracy of ImmunoXpert™ to currently available lab measures (WBC, ANC, PCT, CRP), using sensitivity and specificity measures and predetermined cutoffs</measure>
    <time_frame>0-6 days after the initiation of symptoms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis</measure>
    <time_frame>0-6 days after the initiation of symptoms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™ compared to current practice</measure>
    <time_frame>0-6 days after the initiation of symptoms</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients</measure>
    <time_frame>0-6 days after the initiation of symptoms</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">583</enrollment>
  <condition>Lower Respiratory Tract Infection</condition>
  <condition>Acute Bronchitis</condition>
  <condition>Pneumonia</condition>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <condition>Upper Respiratory Tract Infection</condition>
  <arm_group>
    <arm_group_label>LRTI patients</arm_group_label>
    <description>Patients with suspicion of LRTI, excluding episodes of COPD exacerbations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-infectious patients</arm_group_label>
    <description>Afebrile patients with no apparent infectious disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LRTI patients with COPD</arm_group_label>
    <description>Patients with suspicion of LRTI in a sub-group of patients with COPD</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Venous blood and nasal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include eligible patients aged 18 years and older of both genders&#xD;
        that attend the emergency department or affiliated community clinics due to a suspected&#xD;
        LRTI, or due to a non-infectious disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years and older who agree (or their legal guardian agree) to sign an&#xD;
             informed consent will be eligible for inclusion.&#xD;
&#xD;
          -  The LRTI cohorts should also fulfill the following criteria:&#xD;
&#xD;
               -  Peak measured (not tactile, self-reported acceptable) temperature ≥ 37.8°C&#xD;
                  (100°F) within the last 7 days (AND)&#xD;
&#xD;
               -  Symptoms duration ≤7 days (AND)&#xD;
&#xD;
               -  Clinical suspicion of LRTI or pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oral/intravenous/intramuscular antibiotic treatment of over 48/12/12 hours' duration&#xD;
             at time of enrollment (respectively), unless temperature ≥ 37.8°C was measured within&#xD;
             the last 2 days&#xD;
&#xD;
          -  Another episode of an acute infection during the last 2 weeks&#xD;
&#xD;
          -  Congenital immune deficiency (CID)&#xD;
&#xD;
          -  A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV),&#xD;
             or hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current treatment with immune-suppressive or immune-modulating therapies including&#xD;
             without limitations:&#xD;
&#xD;
               -  Use of high dose steroids &gt;1 mg/kg/day prednisone or equivalent in the past two&#xD;
                  weeks&#xD;
&#xD;
               -  Monoclonal antibodies&#xD;
&#xD;
               -  Intravenous immunoglobulin (IVIG)&#xD;
&#xD;
               -  Cyclosporine, Cyclophosphamide, Tacrolimus&#xD;
&#xD;
               -  Granulocyte/Monocyte colony stimulating factor (G/GM-CSF)&#xD;
&#xD;
               -  Anti-Tumor Necrosis Factor (TNF) agents&#xD;
&#xD;
               -  Interferon (of all kinds)&#xD;
&#xD;
          -  Other severe illnesses that affect life expectancy and quality of life such as:&#xD;
&#xD;
               -  Moderate to severe psychomotor retardation&#xD;
&#xD;
               -  Post-transplant patients (including solid organs, allogeneic/autologous stem cell&#xD;
                  transplantation)&#xD;
&#xD;
               -  Moderate to severe congenital metabolic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mical Paul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rambam Health Care Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <link>
    <url>http://www.me-med.com/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.</citation>
    <PMID>25785720</PMID>
  </reference>
  <reference>
    <citation>Eden E, Srugo I, Gottlieb T, Navon R, Boico O, Cohen A, Bamberger E, Klein A, Oved K. Diagnostic accuracy of a TRAIL, IP-10 and CRP combination for discriminating bacterial and viral etiologies at the Emergency Department. J Infect. 2016 Aug;73(2):177-80. doi: 10.1016/j.jinf.2016.05.002. Epub 2016 May 30. No abstract available.</citation>
    <PMID>27255416</PMID>
  </reference>
  <reference>
    <citation>van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22.</citation>
    <PMID>28012942</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03011515
org study id: MM-1005-OB
nct id: NCT03011515
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to validate the diagnostic accuracy of a novel host-response
      based diagnostic tool for differentiating between bacterial and viral etiologies in adult
      patients aged 18 years and older with clinical suspicion of lower respiratory tract
      infections (LRTI)
observational model: Cohort
time perspective: Prospective
measure: To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI
time frame: 0-6 days after the initiation of symptoms
measure: To compare the diagnostic accuracy of ImmunoXpert™ to currently available lab measures (WBC, ANC, PCT, CRP), using sensitivity and specificity measures and predetermined cutoffs
time frame: 0-6 days after the initiation of symptoms
measure: To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis
time frame: 0-6 days after the initiation of symptoms
measure: To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™ compared to current practice
time frame: 0-6 days after the initiation of symptoms
measure: To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients
time frame: 0-6 days after the initiation of symptoms
arm group label: LRTI patients
description: Patients with suspicion of LRTI, excluding episodes of COPD exacerbations
arm group label: Non-infectious patients
description: Afebrile patients with no apparent infectious disease
arm group label: LRTI patients with COPD
description: Patients with suspicion of LRTI in a sub-group of patients with COPD
Venous blood and nasal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mical Paul, MD
role: Principal Investigator
affiliation: Rambam Health Care Campus
facility: 
country: Israel
country: United Kingdom
url: http://www.me-med.com/
description: Related Info
citation: Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015.
PMID: 25785720
citation: Eden E, Srugo I, Gottlieb T, Navon R, Boico O, Cohen A, Bamberger E, Klein A, Oved K. Diagnostic accuracy of a TRAIL, IP-10 and CRP combination for discriminating bacterial and viral etiologies at the Emergency Department. J Infect. 2016 Aug;73(2):177-80. doi: 10.1016/j.jinf.2016.05.002. Epub 2016 May 30. No abstract available.
PMID: 27255416
citation: van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22.
PMID: 28012942
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Bronchitis
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive