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/NCT06002802</url>
    </required_header>
    <id_info>
      <org_study_id>TTU 07.905/07.909</org_study_id>
      <nct_id>NCT06002802</nct_id>
    </id_info>
    <brief_title>Study on Infectious Mononucleosis in Munich</brief_title>
    <acronym>IMMUC</acronym>
    <official_title>Study on Biomarkers and Causative Factors of Complicated and/or Protracted Epstein-Barr Virus-associated Infectious Mononucleosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Technical University of Munich</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Helmholtz Munich, Munich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>German Cancer Research Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ludwig-Maximilians-Universität, Munich</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hannover Medical School, Hannover</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Albert-Ludwigs University Freiburg, Freiburg</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>German Center for Infection Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Technical University of Munich</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>
        This observational clinical study aims at the identification of novel biomarkers and&#xD;
        causative factors of complicated and/or protracted Epstein-Barr virus-associated infectious&#xD;
        mononucleosis (IM).&#xD;
  &#xD;
        Clinical, biochemical, and routine virological data were collected from 200 patients with IM,&#xD;
        novel analytical tools were implemented, and immunological and virological experimental data&#xD;
        were generated using blood samples and mouthwashes. Patients have been investigated within&#xD;
        four weeks after the onset of symptoms as well as one month and six months thereafter.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        EBV-associated diseases are a severe and global health problem, and novel tools and targets&#xD;
        for a better pathogenetic understanding, diagnosis, treatment, and prevention are clearly&#xD;
        needed. Here we propose to use several novel experimental approaches to investigate&#xD;
        immunological, virological, biochemical, and clinical features in an observational study on&#xD;
        Munich IM patients.&#xD;
  &#xD;
        This study aims at identifying biomarkers and causative factors of protracted and/or&#xD;
        complicated IM to facilitate the development of novel approaches to early diagnosis, therapy,&#xD;
        and prevention of severe, life-threatening, and chronic EBV-associated diseases, including&#xD;
        post-viral syndromes.&#xD;
  &#xD;
        Two hundred patients with IM onset within the last four weeks were recruited from Munich&#xD;
        health care institutions and were re-investigated at one and six months after the onset of&#xD;
        symptoms. A novel diagnostic scoring system was developed to indicate the severity,&#xD;
        complexity, and protraction of symptoms.&#xD;
  &#xD;
        Investigated clinical parameters, including reported symptoms and physical signs of IM, as&#xD;
        well as candidate risk factors in the medical history of patients and family members.&#xD;
        Peripheral blood was analysed by established and novel analytical assays to determine the&#xD;
        immunological and virological phenotypes of IM, and viral load was determined in mouthwashes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2016</start_date>
    <completion_date type="Actual">August 31, 2020</completion_date>
    <primary_completion_date type="Actual">August 31, 2020</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>Severity</measure>
      <time_frame>Six months</time_frame>
      <description>Maximal severity of symptoms during the course of IM according the the IMMUC-Score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Complexity</measure>
      <time_frame>Six months</time_frame>
      <description>Maximal complexity of symptoms during the course of IM according the the IMMUC-Score</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Protraction</measure>
      <time_frame>Six months</time_frame>
      <description>Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immune status</measure>
      <time_frame>Within four weeks post symptom onset and at one and six months thereafter.</time_frame>
      <description>Cellular and humoral immune status, EBV viral load, antibodies against EBV proteome.</description>
    </secondary_outcome>
    <enrollment type="Actual">200</enrollment>
    <condition>Infectious Mononucleosis</condition>
    <condition>Epstein-Barr Virus Infections</condition>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood, mouthwashes&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          200 patients with infectious mononucleosis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          IM onset within the last four weeks, with at least one of four typical clinical findings&#xD;
          (tonsillopharyngitis, fever, lymphadenopathy, fatigue) and virological findings indicating&#xD;
          primary EBV infection (EBV-specific antibodies, EBV DNA).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnancy, transfusion, and/or transplantation during the last year, and/or no informed&#xD;
          consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>39 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich &amp; Munich Municipal Hospital</name>
        <address>
          <city>Munich</city>
          <state>Bavaria</state>
          <zip>80804</zip>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <link>
      <url>https://www.gesundheitsforschung-bmbf.de/de/epstein-barr-virus-von-harmlos-bis-folgenschwer-7238.php</url>
      <description>Federal Ministry of Education and Research</description>
    </link>
    <link>
      <url>https://www.dzif.de/en/epstein-barr-virus-harmless-severe-consequences</url>
      <description>German Center for Infection Research</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>EBV</keyword>
    <keyword>Pfeiffer's glandular fever</keyword>
    <keyword>Post-viral syndrome</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</mesh_term>
      <mesh_term>Epstein-Barr Virus Infections</mesh_term>
      <mesh_term>Infectious Mononucleosis</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/NCT06002802
  org study id: TTU 07.905/07.909
  nct id: NCT06002802
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This observational clinical study aims at the identification of novel biomarkers and
        causative factors of complicated and/or protracted Epstein-Barr virus-associated infectious
        mononucleosis (IM).
  
        Clinical, biochemical, and routine virological data were collected from 200 patients with IM,
        novel analytical tools were implemented, and immunological and virological experimental data
        were generated using blood samples and mouthwashes. Patients have been investigated within
        four weeks after the onset of symptoms as well as one month and six months thereafter.
  EBV-associated diseases are a severe and global health problem, and novel tools and targets
        for a better pathogenetic understanding, diagnosis, treatment, and prevention are clearly
        needed. Here we propose to use several novel experimental approaches to investigate
        immunological, virological, biochemical, and clinical features in an observational study on
        Munich IM patients.
  
        This study aims at identifying biomarkers and causative factors of protracted and/or
        complicated IM to facilitate the development of novel approaches to early diagnosis, therapy,
        and prevention of severe, life-threatening, and chronic EBV-associated diseases, including
        post-viral syndromes.
  
        Two hundred patients with IM onset within the last four weeks were recruited from Munich
        health care institutions and were re-investigated at one and six months after the onset of
        symptoms. A novel diagnostic scoring system was developed to indicate the severity,
        complexity, and protraction of symptoms.
  
        Investigated clinical parameters, including reported symptoms and physical signs of IM, as
        well as candidate risk factors in the medical history of patients and family members.
        Peripheral blood was analysed by established and novel analytical assays to determine the
        immunological and virological phenotypes of IM, and viral load was determined in mouthwashes.
  observational model: Cohort
  time perspective: Prospective
  measure: Severity
  time frame: Six months
  description: Maximal severity of symptoms during the course of IM according the the IMMUC-Score.
  measure: Complexity
  time frame: Six months
  description: Maximal complexity of symptoms during the course of IM according the the IMMUC-Score
  measure: Protraction
  time frame: Six months
  description: Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.
  measure: Immune status
  time frame: Within four weeks post symptom onset and at one and six months thereafter.
  description: Cellular and humoral immune status, EBV viral load, antibodies against EBV proteome.
  Blood, mouthwashes
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 39 Years
  healthy volunteers: No
  facility: 
  country: Germany
  url: https://www.gesundheitsforschung-bmbf.de/de/epstein-barr-virus-von-harmlos-bis-folgenschwer-7238.php
  description: Federal Ministry of Education and Research
  url: https://www.dzif.de/en/epstein-barr-virus-harmless-severe-consequences
  description: German Center for Infection Research
  responsible party type: Sponsor
  mesh term: Communicable Diseases
  mesh term: Infections
  mesh term: Epstein-Barr Virus Infections
  mesh term: Infectious Mononucleosis
  sharing ipd: Undecided