<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/NCT03308227</url>
  </required_header>
  <id_info>
    <org_study_id>2017ZDSYLL051-P01</org_study_id>
    <nct_id>NCT03308227</nct_id>
  </id_info>
  <brief_title>Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients</brief_title>
  <official_title>Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cttq</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Southeast University, China</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 study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in&#xD;
      septic shock patients comparing with non-septic shock patients to confirm the impact of&#xD;
      septic shock on PK/PD of linezolid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A wide array of pathophysiological changes occurring in severe sepsis and septic shock&#xD;
      patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and&#xD;
      tissue distributions of linezolid achieving effective concentrations are key factors of&#xD;
      successful clinical outcomes. To the best of our knowledge, no observational clinical studies&#xD;
      are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in&#xD;
      septic shock patients. Severe pneumonia patients known or suspected to be caused by&#xD;
      Gram-positive pathogens will be considered eligible for the study when the attending&#xD;
      physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid&#xD;
      concentrations of linezolid are measured in each group at steady state. In an in vitro PK&#xD;
      Model, concentration-time curve is drawn to calculate %T&gt;MIC or AUC0-24h/MIC. Linezolid&#xD;
      pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 20, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2018</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>The plasma and bronchoalveolar lavage fluid concentrations of linezolid</measure>
    <time_frame>Baseline, Day 3, Day 7</time_frame>
    <description>The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bacterial eradication</measure>
    <time_frame>Baseline, Day 3, Day 7</time_frame>
    <description>blood and respiratory secretions culture</description>
  </secondary_outcome>
  <other_outcome>
    <measure>mortality</measure>
    <time_frame>28-mortality and 60-mortality</time_frame>
    <description>the outcomes of the patients will be recorded</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <description>septic shock patients;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conrol Group</arm_group_label>
    <description>non-septic shock patients;</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed as severe pneumonia requiring mechanical ventilatory support.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. between 18 years old and 75 years old;&#xD;
&#xD;
          2. Admitted to the ICU;&#xD;
&#xD;
          3. Expectation, in the opinion of the investigator, that the patients' infection will&#xD;
             require ICU stay more than 3 days;&#xD;
&#xD;
          4. Patients diagnosed as severe pneumonia requiring mechanical ventilatory support;&#xD;
&#xD;
          5. Severe pneumonia known or suspected to be caused by Gram-positive pathogens;&#xD;
&#xD;
          6. Expected to treat with linezolid.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to take bronchoalveolar lavage via bronchofiberscopy;&#xD;
&#xD;
          2. Allergy, hypersensitivity or a serious reaction to linezolid;&#xD;
&#xD;
          3. Treatment with linezolid during the previous 72 hours;&#xD;
&#xD;
          4. Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yingzi Yingzi, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southeast University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Haibo Qiu, PHD</last_name>
    <phone>8602583262550</phone>
    <email>haiboq2000@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yingzi Huang, PHD</last_name>
    <phone>8602583262550</phone>
    <email>Yz_huang@126.com</email>
  </overall_contact_backup>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 8, 2017</last_update_submitted>
  <last_update_submitted_qc>October 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jingyuan,Xu</investigator_full_name>
    <investigator_title>chief doctor</investigator_title>
  </responsible_party>
  <keyword>Linezolid; PK/PD; Septic shock</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</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/NCT03308227
org study id: 2017ZDSYLL051-P01
nct id: NCT03308227
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in
      septic shock patients comparing with non-septic shock patients to confirm the impact of
      septic shock on PK/PD of linezolid.
A wide array of pathophysiological changes occurring in severe sepsis and septic shock
      patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and
      tissue distributions of linezolid achieving effective concentrations are key factors of
      successful clinical outcomes. To the best of our knowledge, no observational clinical studies
      are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in
      septic shock patients. Severe pneumonia patients known or suspected to be caused by
      Gram-positive pathogens will be considered eligible for the study when the attending
      physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid
      concentrations of linezolid are measured in each group at steady state. In an in vitro PK
      Model, concentration-time curve is drawn to calculate %T>MIC or AUC0-24h/MIC. Linezolid
      pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.
observational model: Cohort
time perspective: Prospective
measure: The plasma and bronchoalveolar lavage fluid concentrations of linezolid
time frame: Baseline, Day 3, Day 7
description: The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state
measure: Bacterial eradication
time frame: Baseline, Day 3, Day 7
description: blood and respiratory secretions culture
measure: mortality
time frame: 28-mortality and 60-mortality
description: the outcomes of the patients will be recorded
arm group label: Experimental Group
description: septic shock patients;
arm group label: Conrol Group
description: non-septic shock patients;
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yingzi Yingzi, PHD
role: Principal Investigator
affiliation: Southeast University
last name: Haibo Qiu, PHD
phone: 8602583262550
email: haiboq2000@163.com
last name: Yingzi Huang, PHD
phone: 8602583262550
email: Yz_huang@126.com
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jingyuan,Xu
investigator title: chief doctor
mesh term: Shock, Septic
mesh term: Shock
sharing ipd: No