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/NCT06039696</url>
    </required_header>
    <id_info>
      <org_study_id>NFEC-2020-255</org_study_id>
      <nct_id>NCT06039696</nct_id>
    </id_info>
    <brief_title>Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection</brief_title>
    <official_title>Clinical Application of Pathogenic Metagenomic Next-generation Sequencing to Optimize the Diagnosis of Decompensated Cirrhosis Infection: a Multicenter, Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanfang Hospital, Southern Medical University</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 goal of this observational study is to learn about clinical application of pathogenic&#xD;
        metagenomic next-generation sequencing to optimize the diagnosis of infection in&#xD;
        decompensated cirrhotic patients. The main questions it aims to answer are:&#xD;
  &#xD;
          1. mNGS testing in optimizing anti-infective drug use in patients with acute&#xD;
             decompensation, including response to empiric antibiotic therapy.&#xD;
  &#xD;
          2. Proportion of patients with re-compensation.&#xD;
  &#xD;
          3. The positive rate of mNGS in patients with acute decompensated cirrhosis and the&#xD;
             characteristics of pathogen.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 10, 2021</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Actual">June 30, 2021</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>Positive rate of mNGS test in AD patients</measure>
      <time_frame>at enrolment</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>28- and 90-day transplantation-free mortality</measure>
      <time_frame>at 28-day and 90-day after enrolment</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of development of acute kidney injury and acute-on-chronic liver failure</measure>
      <time_frame>up to 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of hospital readmissions due to infections</measure>
      <time_frame>up to 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of progression to SIRS or sepsis</measure>
      <time_frame>up to 12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Consistency with blood culture results</measure>
      <time_frame>at enrollment</time_frame>
      <description>Concordance of mNGS With Other traditional Testing on Pathogens</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Cirrhosis, Liver</condition>
    <arm_group>
      <arm_group_label>patients received mNGS test</arm_group_label>
      <description>After enrolment, patients will receive mNGS test.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patient with diagnosis of cirrhosis hospitalized for acute decompensation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years old.&#xD;
  &#xD;
            -  Diagnosis of cirrhosis, previously known or not, of any etiology, histologically&#xD;
               proven or not.&#xD;
  &#xD;
            -  Acute decompensation: ascites, digestive hemorrhage or hepatic encephalopathy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 80 years old.&#xD;
  &#xD;
            -  Malignancy of liver or other organs (including leukemia).&#xD;
  &#xD;
            -  Receiving immunosuppressive agents for non-hepatic diseases.&#xD;
  &#xD;
            -  HIV infection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chen Jinjun</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chen Jinjun</last_name>
      <phone>+86 020 62787310</phone>
      <email>chjj@smu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nanfang Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>CHEN Jinjun</last_name>
        <phone>+86 020 62787310</phone>
        <email>chjj@smu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Liver Cirrhosis</mesh_term>
      <mesh_term>Fibrosis</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/NCT06039696
  org study id: NFEC-2020-255
  nct id: NCT06039696
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about clinical application of pathogenic
        metagenomic next-generation sequencing to optimize the diagnosis of infection in
        decompensated cirrhotic patients. The main questions it aims to answer are:
  
          1. mNGS testing in optimizing anti-infective drug use in patients with acute
             decompensation, including response to empiric antibiotic therapy.
  
          2. Proportion of patients with re-compensation.
  
          3. The positive rate of mNGS in patients with acute decompensated cirrhosis and the
             characteristics of pathogen.
  observational model: Cohort
  time perspective: Prospective
  measure: Positive rate of mNGS test in AD patients
  time frame: at enrolment
  measure: 28- and 90-day transplantation-free mortality
  time frame: at 28-day and 90-day after enrolment
  measure: The rate of development of acute kidney injury and acute-on-chronic liver failure
  time frame: up to 12 weeks
  measure: Proportion of hospital readmissions due to infections
  time frame: up to 12 weeks
  measure: Proportion of progression to SIRS or sepsis
  time frame: up to 12 weeks
  measure: Consistency with blood culture results
  time frame: at enrollment
  description: Concordance of mNGS With Other traditional Testing on Pathogens
  arm group label: patients received mNGS test
  description: After enrolment, patients will receive mNGS test.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Chen Jinjun
  role: Principal Investigator
  affiliation: Nanfang Hospital, Southern Medical University
  last name: Chen Jinjun
  phone: +86 020 62787310
  email: chjj@smu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Liver Cirrhosis
  mesh term: Fibrosis