<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/NCT03245632</url>
  </required_header>
  <id_info>
    <org_study_id>SRRSH-CRKP</org_study_id>
    <nct_id>NCT03245632</nct_id>
  </id_info>
  <brief_title>Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China</brief_title>
  <official_title>Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Run Run Shaw Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Run Run Shaw 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>
      Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection.&#xD;
      Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the&#xD;
      clinical therapy be very difficult. However, there is not much empirical data as to the&#xD;
      prevalence, risk factors, characteristics, and the rationality of the current therapy for the&#xD;
      CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors,&#xD;
      characteristics, and the rationality of the current therapy for the CRKP infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All the patients with culture positive of Klebsiella pneumoniae were screened and reported to&#xD;
      the the clinical doctors and confirmed by them. And the clinical characteristics of the&#xD;
      patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the&#xD;
      prevalence, risk factors, characteristics, and the rationality of the current therapy for the&#xD;
      CRKP infection&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>CRKP infection</measure>
    <time_frame>7 days</time_frame>
    <description>Culture postitive results confirmed the infection of CRKP</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Klebsiella Pneumoniae Infection</condition>
  <arm_group>
    <arm_group_label>Carbapenem-Resistant K. pneumoniae</arm_group_label>
    <description>Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbapenem-Sensitive K. pneumoniae</arm_group_label>
    <description>Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Carbapenem-Resistant Klebsiella pneumoniae</intervention_name>
    <description>no intervention, this is an obervational study.</description>
    <arm_group_label>Carbapenem-Resistant K. pneumoniae</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients admitted to all study hospitals and met the aboved eligibility&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  new confirmed noscomial infection of CRKP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt;18, or &gt;85 years old; Mixed infection of CRKP and other microbes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yun-song YU, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Run Run Shaw Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ying-zhi FANG, Master</last_name>
    <phone>+86 57186006811</phone>
    <email>fyz4817@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Run Run Shaw Hospital</investigator_affiliation>
    <investigator_full_name>Jian-cang Zhou M.D.</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Klebsiella Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>For the time, we are not yet make determined to take the IPD plan</ipd_description>
  </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/NCT03245632
org study id: SRRSH-CRKP
nct id: NCT03245632
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection.
      Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the
      clinical therapy be very difficult. However, there is not much empirical data as to the
      prevalence, risk factors, characteristics, and the rationality of the current therapy for the
      CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors,
      characteristics, and the rationality of the current therapy for the CRKP infection.
All the patients with culture positive of Klebsiella pneumoniae were screened and reported to
      the the clinical doctors and confirmed by them. And the clinical characteristics of the
      patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the
      prevalence, risk factors, characteristics, and the rationality of the current therapy for the
      CRKP infection
observational model: Case-Control
time perspective: Prospective
measure: CRKP infection
time frame: 7 days
description: Culture postitive results confirmed the infection of CRKP
arm group label: Carbapenem-Resistant K. pneumoniae
description: Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection.
arm group label: Carbapenem-Sensitive K. pneumoniae
description: Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection.
intervention type: Other
intervention name: Carbapenem-Resistant Klebsiella pneumoniae
description: no intervention, this is an obervational study.
arm group label: Carbapenem-Resistant K. pneumoniae
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yun-song YU, Doctor
role: Principal Investigator
affiliation: Sir Run Run Shaw Hospital
last name: Ying-zhi FANG, Master
phone: +86 57186006811
email: fyz4817@126.com
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sir Run Run Shaw Hospital
investigator full name: Jian-cang Zhou M.D.
investigator title: Prof.
mesh term: Pneumonia
mesh term: Klebsiella Infections
sharing ipd: Undecided
ipd description: For the time, we are not yet make determined to take the IPD plan