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/NCT06011902</url>
    </required_header>
    <id_info>
      <org_study_id>RESORT</org_study_id>
      <nct_id>NCT06011902</nct_id>
    </id_info>
    <brief_title>A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome</brief_title>
    <official_title>A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <brief_summary>
      <textblock>
        This is a multi-center, retrospective clinical study to analyze the clinical features,&#xD;
        laboratory indicators, imaging changes, treatment options and long-term prognosis in patients&#xD;
        with sever fever with thrombocytopenia syndrome. All hospitalized patients with sever fever&#xD;
        with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic&#xD;
        medical record system of 8 centers, and demographics, hospitalization information, clinical&#xD;
        information, laboratory or imaging examinations, treatment options, and outcomes were&#xD;
        collected.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 25, 2021</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The presense of clinical symptoms of patients at 3 months and 6 months after discharge</measure>
      <time_frame>3 months,6 months</time_frame>
      <description>The number and severity of clinical symptoms of patients.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with different outcome of disease</measure>
      <time_frame>6 months</time_frame>
      <description>Number of participants who experience these events:&#xD;
  discharge with improvement&#xD;
  death&#xD;
  automatic discharge</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Severe Fever With Thrombocytopenia Syndrome</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome from 8&#xD;
          centers in Hubei Province, China.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age and gender are not limited;&#xD;
  &#xD;
            -  Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome have&#xD;
               at least one of the following laboratory test results: serum severe fever with&#xD;
               thrombocytopenia syndrome bunyavirus (SFTSV)-specific IgM antibody positive or IgG&#xD;
               antibody level increased more than 4 times; or positive for SFTSV RNA; or positive for&#xD;
               SFTSV nucleic acid detected by real-time fluorescent quantitative RT-PCR; or SFTSV&#xD;
               isolated from case specimens.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who were found to be positive for other tick-borne pathogens by PCR analysis&#xD;
               of blood samples in the acute phase;&#xD;
  &#xD;
            -  It is difficult to conduct outpatient follow-up due to mental disorders, dementia,&#xD;
               combined diseases such as osteoarthropathy, stroke, pulmonary embolism, etc. that lead&#xD;
               to inability to move freely;&#xD;
  &#xD;
            -  No outpatient follow-up visit after discharge, and repeated confirmation by phone call&#xD;
               still unable to get in touch;&#xD;
  &#xD;
            -  Due to living in other places, nursing homes, welfare homes, unable to participate in&#xD;
               outpatient follow-up after making an appointment by phone;&#xD;
  &#xD;
            -  Currently participating in clinical trials of other drugs or medical devices;&#xD;
  &#xD;
            -  The researchers think it is not suitable for inclusion.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Qin Ning, Professor</last_name>
      <phone>+8613971521450</phone>
      <email>qning@vip.sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>NO.1 Peoples Hospital of Guangshui</name>
        <address>
          <city>Guangshui</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>qian Liu</last_name>
        <email>liuqian060685@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Huanggang Central Hospital</name>
        <address>
          <city>Huanggang</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>yaping Li</last_name>
        <email>1061319323@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital Of Luotian County</name>
        <address>
          <city>Huanggang</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>wei Wang</last_name>
        <email>196436547@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology</name>
        <address>
          <city>Macheng</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>yi Zhou</last_name>
        <email>2513478349@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Suizhou Central Hospital</name>
        <address>
          <city>Suizhou</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>tiantong Zhou</last_name>
        <email>2063151328@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qin Ning, professor</last_name>
        <email>qning@vip.sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xianning Central Hospital</name>
        <address>
          <city>Xianning</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>jun Zhu</last_name>
        <email>1356266581@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yichang Third Peoples Hospital</name>
        <address>
          <city>Yichang</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>quan Ming</last_name>
        <email>737695825@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Qin Ning</investigator_full_name>
      <investigator_title>Director and Chair of Department of Infectious Diseases</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Severe Fever with Thrombocytopenia Syndrome</mesh_term>
      <mesh_term>Thrombocytopenia</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Fever</mesh_term>
    </condition_browse>
    <!-- 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/NCT06011902
  org study id: RESORT
  nct id: NCT06011902
  lead sponsor: 
  This is a multi-center, retrospective clinical study to analyze the clinical features,
        laboratory indicators, imaging changes, treatment options and long-term prognosis in patients
        with sever fever with thrombocytopenia syndrome. All hospitalized patients with sever fever
        with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic
        medical record system of 8 centers, and demographics, hospitalization information, clinical
        information, laboratory or imaging examinations, treatment options, and outcomes were
        collected.
  observational model: Cohort
  time perspective: Retrospective
  measure: The presense of clinical symptoms of patients at 3 months and 6 months after discharge
  time frame: 3 months,6 months
  description: The number and severity of clinical symptoms of patients.
  measure: Number of participants with different outcome of disease
  time frame: 6 months
  description: Number of participants who experience these events:
  discharge with improvement
  death
  automatic discharge
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Qin Ning, Professor
  phone: +8613971521450
  email: qning@vip.sina.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Qin Ning
  investigator title: Director and Chair of Department of Infectious Diseases
  mesh term: Severe Fever with Thrombocytopenia Syndrome
  mesh term: Thrombocytopenia
  mesh term: Syndrome
  mesh term: Fever