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/NCT06035796</url>
    </required_header>
    <id_info>
      <org_study_id>Yuting Li111</org_study_id>
      <nct_id>NCT06035796</nct_id>
    </id_info>
    <brief_title>Performance Study of Targeted Sequencing Technology for VAP</brief_title>
    <official_title>Performance Study of Targeted Sequencing Technology for Identification of Respiratory Pathogens and Drug Resistance Factor Analysis in VAP Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Hospital of Jilin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Hospital of Jilin University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Main purpose: To evaluate the feasibility of tNGS for pathogen detection and drug resistance&#xD;
        analysis in VAP patients.&#xD;
  &#xD;
        Research site and research population:&#xD;
  &#xD;
        This study is planned to be conducted in hospitals, targeting VAP patients. Perform clinical&#xD;
        routine testing and tNGS testing on lower respiratory tract samples (BALF) from VAP patients,&#xD;
        and collect patient clinical information. Clinical routine testing includes culture&#xD;
        (necessary), microscopy, serology, PCR, etc., and drug sensitivity tests are conducted on&#xD;
        positive culture samples as needed. Finally, compare the consistency of tNGS detection&#xD;
        results with clinical culture, comprehensive diagnosis, and drug sensitivity results. Further&#xD;
        validation was conducted on consistent negative or inconsistent samples through PCR and mNGS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigators plan to include 150 VAP patients in the ICU. Lower respiratory tract&#xD;
        samples (BALF) from VAP patients were routinely tested and tNGS tested, and clinical&#xD;
        information was collected. Routine clinical tests include culture (necessary), microscopic&#xD;
        examination, serology, PCR, etc., and drug sensitivity tests are performed on positive&#xD;
        culture samples as required. Finally, the consistency of tNGS test results with clinical&#xD;
        culture, comprehensive diagnosis and drug sensitivity results was compared. The uniformly&#xD;
        negative or inconsistent samples were further verified by PCR and mNGS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2025</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>tNGS for pathogen detection rate and drug resistance rate in VAP</measure>
      <time_frame>2years</time_frame>
      <description>Evaluating the feasibility of tNGS for pathogen detection rate and drug resistance rate in VAP patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Consistency rate of pathogen detection of tNGS with clinical practice</measure>
      <time_frame>2 years</time_frame>
      <description>To compare the consistency rate of TNGs-based pathogen detection with clinical&#xD;
  culture, multiple clinical detection methods (PCR/ serology, etc.) and comprehensive diagnosis results in the whole and different types of microorganisms (bacteria/viruses/fungi);&#xD;
  To compare the consistency rate of drug resistance results of TNGs-based drug resistance gene test and clinical drug susceptibility test;&#xD;
  To compare the consistency rate of the responsible pathogen based on tNGS semi-quantitative judgment with the clinical comprehensive diagnosis results.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>VAP - Ventilator Associated Pneumonia</condition>
    <arm_group>
      <arm_group_label>tNGS(targeted second generation sequencing)</arm_group_label>
      <description>tNGS detection of lower respiratory tract samples (BALF) from VAP patients.By means of super-multiple PCR amplification or probe hybridization capture, tNGS can enrich dozens to hundreds of known pathogenic microorganisms and their virulence and drug resistance genes in the samples to be tested, and then conduct high-throughput sequencing.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>non-tNGS(non-targeted second generation sequencing)</arm_group_label>
      <description>Perform routine clinical testing on lower respiratory tract samples (BALF) from VAP patients and collect patient clinical information. Clinical routine testing includes culture (necessary), microscopy, serology, PCR, etc., and drug sensitivity tests are conducted on positive culture samples as needed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tNGS</intervention_name>
      <description>By means of super-multiple PCR amplification or probe hybridization capture, tNGS can enrich dozens to hundreds of known pathogenic microorganisms and their virulence and drug resistance genes in the samples to be tested, and then conduct high-throughput sequencing.</description>
      <arm_group_label>tNGS(targeted second generation sequencing)</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        BALF or sputum&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          VAP patients in the ICU&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1)VAP patients (2) Patients can collect the required test information&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Clearly diagnosed as non-infectious patients&#xD;
  &#xD;
               (2) Insufficient samples or patients unwilling to participate&#xD;
  &#xD;
               (3) Life expectancy is less than 24 hours&#xD;
  &#xD;
               (4) Patients' clinical information cannot be obtained&#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_official>
      <last_name>Dong Zhang</last_name>
      <role>Study Director</role>
      <affiliation>The First Hospital of Jilin University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yuting Li</last_name>
      <phone>13943179756</phone>
      <email>liyuting@jlu.edu.cn</email>
    </overall_contact>
    <link>
      <url>http://pubmed.ncbi.nlm.nih.gov/35622934/</url>
      <description>Clinical application of metagenomic next-generation sequencing technology in the diagnosis and treatment of pulmonary infection pathogens: A prospective single-center study of 138 patients</description>
    </link>
    <results_reference>
      <citation>Li N, Ma X, Zhou J, Deng J, Gu C, Fei C, Cao L, Zhang Q, Tao F. Clinical application of metagenomic next-generation sequencing technology in the diagnosis and treatment of pulmonary infection pathogens: A prospective single-center study of 138 patients. J Clin Lab Anal. 2022 Jul;36(7):e24498. doi: 10.1002/jcla.24498. Epub 2022 May 27.</citation>
      <PMID>35622934</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Pneumonia, Ventilator-Associated</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06035796
  org study id: Yuting Li111
  nct id: NCT06035796
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Main purpose: To evaluate the feasibility of tNGS for pathogen detection and drug resistance
        analysis in VAP patients.
  
        Research site and research population:
  
        This study is planned to be conducted in hospitals, targeting VAP patients. Perform clinical
        routine testing and tNGS testing on lower respiratory tract samples (BALF) from VAP patients,
        and collect patient clinical information. Clinical routine testing includes culture
        (necessary), microscopy, serology, PCR, etc., and drug sensitivity tests are conducted on
        positive culture samples as needed. Finally, compare the consistency of tNGS detection
        results with clinical culture, comprehensive diagnosis, and drug sensitivity results. Further
        validation was conducted on consistent negative or inconsistent samples through PCR and mNGS.
  The investigators plan to include 150 VAP patients in the ICU. Lower respiratory tract
        samples (BALF) from VAP patients were routinely tested and tNGS tested, and clinical
        information was collected. Routine clinical tests include culture (necessary), microscopic
        examination, serology, PCR, etc., and drug sensitivity tests are performed on positive
        culture samples as required. Finally, the consistency of tNGS test results with clinical
        culture, comprehensive diagnosis and drug sensitivity results was compared. The uniformly
        negative or inconsistent samples were further verified by PCR and mNGS.
  observational model: Cohort
  time perspective: Prospective
  measure: tNGS for pathogen detection rate and drug resistance rate in VAP
  time frame: 2years
  description: Evaluating the feasibility of tNGS for pathogen detection rate and drug resistance rate in VAP patients
  measure: Consistency rate of pathogen detection of tNGS with clinical practice
  time frame: 2 years
  description: To compare the consistency rate of TNGs-based pathogen detection with clinical
  culture, multiple clinical detection methods (PCR/ serology, etc.) and comprehensive diagnosis results in the whole and different types of microorganisms (bacteria/viruses/fungi);
  To compare the consistency rate of drug resistance results of TNGs-based drug resistance gene test and clinical drug susceptibility test;
  To compare the consistency rate of the responsible pathogen based on tNGS semi-quantitative judgment with the clinical comprehensive diagnosis results.
  arm group label: tNGS(targeted second generation sequencing)
  description: tNGS detection of lower respiratory tract samples (BALF) from VAP patients.By means of super-multiple PCR amplification or probe hybridization capture, tNGS can enrich dozens to hundreds of known pathogenic microorganisms and their virulence and drug resistance genes in the samples to be tested, and then conduct high-throughput sequencing.
  arm group label: non-tNGS(non-targeted second generation sequencing)
  description: Perform routine clinical testing on lower respiratory tract samples (BALF) from VAP patients and collect patient clinical information. Clinical routine testing includes culture (necessary), microscopy, serology, PCR, etc., and drug sensitivity tests are conducted on positive culture samples as needed.
  intervention type: Device
  intervention name: tNGS
  description: By means of super-multiple PCR amplification or probe hybridization capture, tNGS can enrich dozens to hundreds of known pathogenic microorganisms and their virulence and drug resistance genes in the samples to be tested, and then conduct high-throughput sequencing.
  arm group label: tNGS(targeted second generation sequencing)
  BALF or sputum
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Dong Zhang
  role: Study Director
  affiliation: The First Hospital of Jilin University
  last name: Yuting Li
  phone: 13943179756
  email: liyuting@jlu.edu.cn
  url: http://pubmed.ncbi.nlm.nih.gov/35622934/
  description: Clinical application of metagenomic next-generation sequencing technology in the diagnosis and treatment of pulmonary infection pathogens: A prospective single-center study of 138 patients
  citation: Li N, Ma X, Zhou J, Deng J, Gu C, Fei C, Cao L, Zhang Q, Tao F. Clinical application of metagenomic next-generation sequencing technology in the diagnosis and treatment of pulmonary infection pathogens: A prospective single-center study of 138 patients. J Clin Lab Anal. 2022 Jul;36(7):e24498. doi: 10.1002/jcla.24498. Epub 2022 May 27.
  PMID: 35622934
  responsible party type: Sponsor
  mesh term: Pneumonia, Ventilator-Associated
  sharing ipd: No