<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/NCT04433403</url>
  </required_header>
  <id_info>
    <org_study_id>PMASP</org_study_id>
    <nct_id>NCT04433403</nct_id>
  </id_info>
  <brief_title>Pathogenic Microorganisms in Adult Severe Pneumonia Patients</brief_title>
  <official_title>A Multicenter Clinical Study on the Detection of Pathogenic Microorganisms in Adult Severe Pneumonia Patients in Liaoning Province</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shengjing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chaoyang Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yingkou Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huludao central hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dandong First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fushun Mining Bureau General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Benxi Cental Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shengjing Hospital</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>
      This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in&#xD;
      different cities of Liaoning Province&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pathogenic microorganisms of adult patients with severe pneumonia is detected in this&#xD;
      study. Clinical treatment does not involve , so it meets the ethical requirements. The&#xD;
      clinical data, laboratory test results and imaging data of adult severe pneumonia patients in&#xD;
      different hospitals in different cities are recorded. The pathogenic microorganism is&#xD;
      detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage&#xD;
      fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of&#xD;
      adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 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>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province</measure>
    <time_frame>2020.7-2023.12</time_frame>
    <description>Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pathogenic Microorganism of Serious Pneumonia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pathogenic microorganism</intervention_name>
    <description>Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Severe pneumonia patients, aged 18 years and above, gender unlimited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Meet the standard of severe pneumonia： Main standards： Requiring mechanical&#xD;
             ventilation or septic shock requiring vasoconstrictor therapy.&#xD;
&#xD;
        Secondary standards：(only if 3 items are met) Disturbance of consciousness; respiratory&#xD;
        rate ≥ 30 times/min; PaO2/FiO2 ≤ 250, or PaO2 &lt; 60mmHg; azotemia (BUN ≥ 7.12mmol / L);&#xD;
        hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia&#xD;
        (WBC &lt; 4 × 109 / L); thrombocytopenia (&lt; 10 × 109 / L); hypothermia (T &lt; 36 ℃).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF&#xD;
             samples&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shengjing hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shengjing Hospital</investigator_affiliation>
    <investigator_full_name>Hongyu Zhao</investigator_full_name>
    <investigator_title>deputy director of emergency department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04433403
org study id: PMASP
nct id: NCT04433403
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in
      different cities of Liaoning Province
The pathogenic microorganisms of adult patients with severe pneumonia is detected in this
      study. Clinical treatment does not involve , so it meets the ethical requirements. The
      clinical data, laboratory test results and imaging data of adult severe pneumonia patients in
      different hospitals in different cities are recorded. The pathogenic microorganism is
      detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage
      fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of
      adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical
      treatment.
observational model: Case-Only
time perspective: Prospective
measure: Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province
time frame: 2020.7-2023.12
description: Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing
intervention type: Other
intervention name: pathogenic microorganism
description: Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shengjing Hospital
investigator full name: Hongyu Zhao
investigator title: deputy director of emergency department
mesh term: Pneumonia