<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/NCT04413305</url>
  </required_header>
  <id_info>
    <org_study_id>KY2019-429KP</org_study_id>
    <nct_id>NCT04413305</nct_id>
  </id_info>
  <brief_title>WGS-guided Tracking and Infection Control Measures of CRKP</brief_title>
  <official_title>WGS-guided Tracking and Infection Control Measures of Carbapenem-resistant Klebsiella Pneumoniae</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sumitomo Pharmaceuticals (Suzhou) Co. Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The objective of this study is to investigate the effect of the infection control measures&#xD;
      based on the active screening of carbapenem-resistant Klebsiella pneumoniae and whole-genome&#xD;
      based tracking and surveillance though the hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 28, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analysis of transmission pattern and route pre and post WGS-based tracking</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Klebsiella Pneumoniae Infection</condition>
  <arm_group>
    <arm_group_label>WGS-based screen and control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>screen of CRKP and infection control measure</intervention_name>
    <description>For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.</description>
    <arm_group_label>WGS-based screen and control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient was admitted to the ICU of neurosurgery in the west hospital of huashan&#xD;
             hospital affiliated to fudan university from September 2019 to September 2021, or&#xD;
             transferred from the ICU of another hospital&#xD;
&#xD;
          2. The patient is more than 18 years old and less than 80 years old, regardless of&#xD;
             gender.&#xD;
&#xD;
          3. Informed consent of the patient;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients participating in other clinical trials at the same time&#xD;
&#xD;
          2. Pregnant&#xD;
&#xD;
        4. People who will affect the outcome of the study: whose specimens could not be received&#xD;
        or not enough for testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Infectious department of Huashan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenhong Zhang</last_name>
      <phone>(86)52889999</phone>
      <email>zhangwenhong@fudan.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</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>Professor</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>
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Klebsiella 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>


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/NCT04413305
org study id: KY2019-429KP
nct id: NCT04413305
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to investigate the effect of the infection control measures
      based on the active screening of carbapenem-resistant Klebsiella pneumoniae and whole-genome
      based tracking and surveillance though the hospital.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Evaluate the influence of WGS-based screen and control measures on the CRKP occurrence rate
time frame: 2 years
measure: Analysis of transmission pattern and route pre and post WGS-based tracking
time frame: 2 years
arm group label: WGS-based screen and control group
arm group type: Experimental
description: For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.
arm group label: Non-intervention
arm group type: No Intervention
description: Non-intervention
intervention type: Other
intervention name: screen of CRKP and infection control measure
description: For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.
arm group label: WGS-based screen and control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Wen-hong Zhang
investigator title: Professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Pneumonia
mesh term: Klebsiella Infections
sharing ipd: No