<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/NCT03798925</url>
  </required_header>
  <id_info>
    <org_study_id>SRRSH-mNGS-respiratory</org_study_id>
    <nct_id>NCT03798925</nct_id>
  </id_info>
  <brief_title>mNGS for Detection of Pathogens for Pulmonary Infection</brief_title>
  <official_title>Microbiological Diagnostic Performance of Metagenomic Next-generation Sequencing for Pulmonary Infection in Clinical Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Run Run Shaw Hospital</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>
      Pulmonary infections remain the leading causes of morbidity and mortality among patients&#xD;
      worldwide. Pathogen identification is crucial yet difficult for the majority of the cases.&#xD;
      Metagenomic Next-generation Sequencing provides a potential technology for rapid and&#xD;
      untargeted pathogen detection for pulmonary infection. The study is designed observationally&#xD;
      to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of&#xD;
      diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and&#xD;
      bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional&#xD;
      paradigm of serial tests wil be performed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 19, 2018</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>microbiological diagnosis (pathogen of pulmonary infection)</measure>
    <time_frame>through study completion, up to 6 months</time_frame>
    <description>the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pulmonary Infection</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>None Intervention</intervention_name>
    <description>It is observational study</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      bronchoalveolar lavage fluid&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients whose primary diagnosis is pulmonary infetion and bronchoalveolar lavage fluid can&#xD;
        be obtained&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pulmonary infection as the primary diagnosis&#xD;
&#xD;
          -  Bronchoalveolar lavage fluid can be obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  when the primary diagnosis is tumor or connective tissue diseases&#xD;
&#xD;
          -  microbiological diagnosis is confirmed before bronchoalveolar lavage&#xD;
&#xD;
          -  not enough bronchoalveolar lavage fluid for mNGS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying-zhi Fang</last_name>
      <phone>+86 571 86006987</phone>
    </contact>
    <investigator>
      <last_name>Yun-song Yu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Run Run Shaw Hospital</investigator_affiliation>
    <investigator_full_name>Jian-cang Zhou M.D.</investigator_full_name>
    <investigator_title>Department of Infectious Diseases</investigator_title>
  </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>
  </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/NCT03798925
org study id: SRRSH-mNGS-respiratory
nct id: NCT03798925
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pulmonary infections remain the leading causes of morbidity and mortality among patients
      worldwide. Pathogen identification is crucial yet difficult for the majority of the cases.
      Metagenomic Next-generation Sequencing provides a potential technology for rapid and
      untargeted pathogen detection for pulmonary infection. The study is designed observationally
      to investigate if mNGS is superior to traditional paradigm of serial tests in the aspect of
      diagnostic performance. Patients whose primary diagnosis is pulmonary infetion and
      bronchoalveolar lavage fluid can be obtained will be enrolled. Both mNGS and traditional
      paradigm of serial tests wil be performed.
observational model: Case-Only
time perspective: Other
measure: microbiological diagnosis (pathogen of pulmonary infection)
time frame: through study completion, up to 6 months
description: the final microbiological diagnosis (pathogen of pulmonary infection) after using of every detection method and combined with clinical manifestations.
intervention type: Other
intervention name: None Intervention
description: It is observational study
bronchoalveolar lavage fluid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sir Run Run Shaw Hospital
investigator full name: Jian-cang Zhou M.D.
investigator title: Department of Infectious Diseases
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: Undecided