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/NCT05965128</url>
    </required_header>
    <id_info>
      <org_study_id>KY2022-955</org_study_id>
      <nct_id>NCT05965128</nct_id>
    </id_info>
    <brief_title>Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases</brief_title>
    <official_title>Promotion and Application of a New Three-level Etiological Diagnosis Strategy for Fever Clinics in Respiratory Infectious Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huashan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huashan 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>
        Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the&#xD;
        three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and&#xD;
        realizes real-time monitoring and early warning of acute respiratory infectious diseases in&#xD;
        Shanghai.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study mainly includes subjects who enter the outpatient and emergency departments, fever&#xD;
        clinics, and wards of each center from December 2022. According to the clinical&#xD;
        manifestations and epidemiological information of the patients, different step-by-step&#xD;
        detection methods will be adopted to optimize the allocation of clinical resources and&#xD;
        improve the quality of life. This study aims to improve pathogen diagnosis efficiency and&#xD;
        achieve regional respiratory early warning.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">December 2027</completion_date>
    <primary_completion_date type="Anticipated">December 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>the detectioin rate of pathogenic microorganism in each step</measure>
      <time_frame>48 hours</time_frame>
      <description>the detectioin rate of pathogenic microorganism in each step</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>hospitalization rate</measure>
      <time_frame>48 hours</time_frame>
      <description>hospitalization rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rate of critical illness</measure>
      <time_frame>48 hours</time_frame>
      <description>rate of critical illness</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1255</enrollment>
    <condition>Respiratory Infectious Diseases</condition>
    <eligibility>
      <study_pop>
        <textblock>
          this study enrolled patients who were admitted to the fever clinics and emergency room for&#xD;
          influenza-like illness or pneumonia and pathogenic detection was necessary for clincial&#xD;
          diagnosis and treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Acute onset within one week;&#xD;
  &#xD;
            2. 18-70 years old;&#xD;
  &#xD;
            3. Present with pneumonia (present with pulmonary signs or radiological changes) or&#xD;
               influenza-like illness (including the following symptoms: sudden onset of fever (&gt;38&#xD;
               ℃),plus cough and/or other respiratory symptoms such as shortness of breath plus one&#xD;
               or more systemic symptoms (fatigue, headache ect.))&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Unable to collect nasal/nasopharyngeal swab/wash/aspirate due to structural disorder&#xD;
               or mental problem.&#xD;
  &#xD;
            2. Patients with psycological problem or unconsciousness who cannot tell the disease&#xD;
               history and cooperate with medical examinations;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wenhong Zhang, M.D.</last_name>
      <phone>13801844344</phone>
      <email>zhangwenhong@fudan.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jingwen Ai, M.D.</last_name>
      <phone>13764990804</phone>
      <email>Jingwenai1990@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Gansu Provincial People's Hospital</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaojun Chen, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Heilongjiang Provincial Hospital</name>
        <address>
          <city>Harbin</city>
          <state>Heilongjinag</state>
          <zip>1500036</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaoli Hu, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Inner Mongolia Autonomous Region</name>
        <address>
          <city>Hohhot</city>
          <state>Inner Mongolia</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jihong An, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Suzhou University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaoping Huang, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Xuzhou Medical University</name>
        <address>
          <city>Xuzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xuebing Yan, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shenyang Sixth People's Hospital</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ye Gu, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shandong University Qilu Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lintao Sai, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jining Public Health Center</name>
        <address>
          <city>Jining</city>
          <state>Shandong</state>
          <zip>0537-7970121</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Kaixue Lv, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fudan University Affiliated Huashan Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongyu Wang</last_name>
        <phone>17717366509</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Shanxi Medical University</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Liaoyun Zhang, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital of Yunnan Province</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jiawei Geng, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ruian City People's Hospital</name>
        <address>
          <city>Rui'an</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Liang Hong, M.D.</last_name>
        <phone>17717366509</phone>
        <email>5738675757@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Huashan Hospital</investigator_affiliation>
      <investigator_full_name>Wen-hong Zhang</investigator_full_name>
      <investigator_title>Director of Division of Infectious Diseases</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Infections</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/NCT05965128
  org study id: KY2022-955
  nct id: NCT05965128
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Relying on fever clinics, this project evaluates the clinical diagnostic efficiency of the
        three-level pathogen diagnostic system, monitors changes in respiratory pathogens, and
        realizes real-time monitoring and early warning of acute respiratory infectious diseases in
        Shanghai.
  This study mainly includes subjects who enter the outpatient and emergency departments, fever
        clinics, and wards of each center from December 2022. According to the clinical
        manifestations and epidemiological information of the patients, different step-by-step
        detection methods will be adopted to optimize the allocation of clinical resources and
        improve the quality of life. This study aims to improve pathogen diagnosis efficiency and
        achieve regional respiratory early warning.
  observational model: Case-Only
  time perspective: Prospective
  measure: the detectioin rate of pathogenic microorganism in each step
  time frame: 48 hours
  description: the detectioin rate of pathogenic microorganism in each step
  measure: hospitalization rate
  time frame: 48 hours
  description: hospitalization rate
  measure: rate of critical illness
  time frame: 48 hours
  description: rate of critical illness
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wenhong Zhang, M.D.
  phone: 13801844344
  email: zhangwenhong@fudan.edu.cn
  last name: Jingwen Ai, M.D.
  phone: 13764990804
  email: Jingwenai1990@126.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Huashan Hospital
  investigator full name: Wen-hong Zhang
  investigator title: Director of Division of Infectious Diseases
  mesh term: Communicable Diseases
  mesh term: Infections
  sharing ipd: No