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/NCT06028217</url>
    </required_header>
    <id_info>
      <org_study_id>CHAPTER-1.7</org_study_id>
      <nct_id>NCT06028217</nct_id>
    </id_info>
    <brief_title>Chinese Hospital Acquired Pneumonia Collaboration Network: Epidemiology, Diagnosis and Treatment</brief_title>
    <acronym>CHAPTER</acronym>
    <official_title>A Prospective Study on Pathogen Investigation, Risk Factors, and Prognostic Factors Analysis of Hospital Acquired Pneumonia (HAP)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ruijin Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ruijin 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>
        The goal of this prospective and observatory study is to learn about the pathogen, clinical&#xD;
        manifestations, prognosis, treatment and antibiotic resistance of bacteria in&#xD;
        hospital-acquired pneumonia patients in China.&#xD;
  &#xD;
        The main purposes of this study are:&#xD;
  &#xD;
          1. clarify the regional differences and changes over time in the pathogen spectrum and&#xD;
             antibiotic resistance rate among HAP patients in China;&#xD;
  &#xD;
          2. build a continuously optimized nationwide HAP pathogen and antibiotic resistance&#xD;
             surveillance network;&#xD;
  &#xD;
          3. identify the molecular epidemiology of common pathogens&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2027</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>mortality at day 28</measure>
      <time_frame>28 days after enrollment</time_frame>
      <description>prognosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>clinical characteristics</measure>
      <time_frame>0 day, 3 days, 7days, 14 days and 28 days after enrollment</time_frame>
      <description>symptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pathogen</measure>
      <time_frame>0 day, 3 days, 7days, 14 days and 28 days after enrollment</time_frame>
      <description>molecular characteristics of responsible pathogen; antibiotic resistance of bacteria</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">4000</enrollment>
    <condition>Hospital-acquired Pneumonia</condition>
    <condition>Antibiotic Resistant Infection</condition>
    <arm_group>
      <arm_group_label>survival group</arm_group_label>
      <description>patients still survive at 28 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mortality group</arm_group_label>
      <description>patients die within 28 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>prognosis status</intervention_name>
      <description>observatory; patients will be divided into survival group and mortality group according to their prognosis at day 28</description>
      <arm_group_label>mortality group</arm_group_label>
      <arm_group_label>survival group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          hospital-acquired pneumonia adult patients with qualified evidence of responsible pathogen&#xD;
          in China&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 years old.&#xD;
  &#xD;
            2. Meets the clinical diagnostic criteria for HAP in the 2018 HAP/VAP guidelines. Chest&#xD;
               X-ray or CT shows new or progressive infiltrative shadows, consolidation shadows, or&#xD;
               ground glass shadows, combined with 2 or more of the following 3 clinical symptoms, to&#xD;
               establish a clinical diagnosis: 1) Fever, body temperature&gt;38 ℃; 2) Purulent airway&#xD;
               secretions; 3) Peripheral blood white blood cell count &gt;10 × 10^9/L or &lt;4 × 10^9/L.&#xD;
  &#xD;
            3. Having qualified evidence of responsible pathogen. On the basis of clinical diagnosis,&#xD;
               one of the following conditions should be met simultaneously: 1) Qualified lower&#xD;
               respiratory tract secretions (neutrophil count &gt;25/low magnification field, epithelial&#xD;
               cell count &lt;10/low magnification field, or a ratio of the two &gt;2.5:1), pathogenic&#xD;
               bacteria cultured through bronchoscopy anti pollution brush (PSB), bronchoalveolar&#xD;
               lavage fluid (BALF), lung tissue or sterile body fluid, and consistent with clinical&#xD;
               manifestations; 2) Pathology, cytopathology, or direct microscopic examination of lung&#xD;
               tissue specimens showing fungi and evidence of tissue damage; 3) The serum IgM&#xD;
               antibodies of atypical pathogens or viruses change from negative to positive, or the&#xD;
               titers of specific IgG antibodies in both acute and recovery phases show a 4-fold or&#xD;
               more change. During the outbreak of respiratory viruses and with a history of&#xD;
               epidemiological contact, respiratory secretions were tested positive for corresponding&#xD;
               virus antigens, nucleic acid tests, or virus culture.&#xD;
  &#xD;
            4. obtained informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those who cannot understand and execute the investigation plan.&#xD;
  &#xD;
            2. Active pulmonary tuberculosis;&#xD;
  &#xD;
            3. Severely immunosuppressed patients: absolute neutrophil count &lt;0.5× 10^9/L,&#xD;
               CD4&lt;200/ml.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
      <investigator_full_name>Jieming QU</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pneumonia</mesh_term>
      <mesh_term>Healthcare-Associated Pneumonia</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/NCT06028217
  org study id: CHAPTER-1.7
  nct id: NCT06028217
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this prospective and observatory study is to learn about the pathogen, clinical
        manifestations, prognosis, treatment and antibiotic resistance of bacteria in
        hospital-acquired pneumonia patients in China.
  
        The main purposes of this study are:
  
          1. clarify the regional differences and changes over time in the pathogen spectrum and
             antibiotic resistance rate among HAP patients in China;
  
          2. build a continuously optimized nationwide HAP pathogen and antibiotic resistance
             surveillance network;
  
          3. identify the molecular epidemiology of common pathogens
  observational model: Cohort
  time perspective: Prospective
  measure: mortality at day 28
  time frame: 28 days after enrollment
  description: prognosis
  measure: clinical characteristics
  time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment
  description: symptoms, physical examinations, comorbidity, laboratory tests, imaging findings and treatment
  measure: pathogen
  time frame: 0 day, 3 days, 7days, 14 days and 28 days after enrollment
  description: molecular characteristics of responsible pathogen; antibiotic resistance of bacteria
  arm group label: survival group
  description: patients still survive at 28 days
  arm group label: mortality group
  description: patients die within 28 days
  intervention type: Other
  intervention name: prognosis status
  description: observatory; patients will be divided into survival group and mortality group according to their prognosis at day 28
  arm group label: mortality group
  arm group label: survival group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Ruijin Hospital
  investigator full name: Jieming QU
  investigator title: Professor
  mesh term: Pneumonia
  mesh term: Healthcare-Associated Pneumonia