<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/NCT03034174</url>
  </required_header>
  <id_info>
    <org_study_id>KE-0254/258/2014</org_study_id>
    <nct_id>NCT03034174</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients</brief_title>
  <official_title>Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients: an Observational, Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lublin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to describe the pharmacokinetics of tigecycline in critically&#xD;
      ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the&#xD;
      frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200&#xD;
      mg loading dose and 100 mg/12h).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective observational study performed on critically ill patients. Inclusion&#xD;
      criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical&#xD;
      and surgical patients will be included. Any type of infections will be included (pulmonary,&#xD;
      abdominal, urinary tract, etc.) Antibiotics regimen includes: tigecycline (200 mg every 12&#xD;
      hours intravenously), meropenem (2 grams every 8 hours intravenously).&#xD;
&#xD;
      Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline&#xD;
      for 3 consecutive days. The standard arterial canula will be used to obtain samples.&#xD;
&#xD;
      In each case CVVHD will be started and continued for at least 3 days' period. 30 minutes&#xD;
      after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms.&#xD;
      Subsequently, supernatant will be collected and frozen.&#xD;
&#xD;
      Serum tigecycline concentration will be measured with high performance liquid chromatography.&#xD;
&#xD;
      Each patient's hemodynamics parameters will be recorded with the use of transpulmonary&#xD;
      thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an&#xD;
      antifungal agent will be given as required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Serum concentration of tigecycline</measure>
    <time_frame>72 hours for each patient from the tigecycline treatment initiation.</time_frame>
    <description>Samples obtain from ICU patients 2, 4, 8 12 hours after each dose of tigecycline for 3 days.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Septic Shock</condition>
  <condition>Antibiotic Resistant Infection</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>tigecycline</arm_group_label>
    <description>Each patient will receive: tigecycline (200 mg q 12 hours i.v.), meropenem (2 g q 8 hours i.v). In each case CVVHD will be started.&#xD;
Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Patients' arterial blood samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical&#xD;
        patients will be included. Any site of infection will be treated in the manner.&#xD;
&#xD;
        In each case CVVHD will be initiated and continued. Each patient will receive 200 mg&#xD;
        tigecycline q 12h, 2 g meropenem q 8 h. Other treatment as required.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who require ICU treatment due to severe sepsis&#xD;
&#xD;
          -  age 18-80 years&#xD;
&#xD;
          -  CVVHD treatment&#xD;
&#xD;
          -  an eligible consent obtained from the patient or his/her attendant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to tigecycline or meropenem&#xD;
&#xD;
          -  contraindication to CVVHD&#xD;
&#xD;
          -  lack of consent to participate in the study&#xD;
&#xD;
          -  age of patients below 18 or above 80 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mirosław Czuczwar, M.D. PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Lublin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michał A Borys, M.D., PhD.</last_name>
    <phone>+48506350569</phone>
    <email>michalborys1@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Paweł Piwowarczyk, M.D.</last_name>
    <phone>+48511285352</phone>
    <email>piwowarczyk.pawel@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>II Department of Anesthesia and Intensive Care, Medical University of Lublin</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michał A Borys, M.D., PhD.</last_name>
      <phone>+48506350569</phone>
      <email>michalborys1@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Paweł Piwowarczyk, M.D.</last_name>
      <phone>+48511285352</phone>
      <email>piwowarczyk.pawel@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>October 20, 2017</last_update_submitted>
  <last_update_submitted_qc>October 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lublin</investigator_affiliation>
    <investigator_full_name>Michał Borys</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>tigecycline</keyword>
  <keyword>pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03034174
org study id: KE-0254/258/2014
nct id: NCT03034174
lead sponsor: 
has dmc: No
The objective of this study is to describe the pharmacokinetics of tigecycline in critically
      ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the
      frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200
      mg loading dose and 100 mg/12h).
This is a prospective observational study performed on critically ill patients. Inclusion
      criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical
      and surgical patients will be included. Any type of infections will be included (pulmonary,
      abdominal, urinary tract, etc.) Antibiotics regimen includes: tigecycline (200 mg every 12
      hours intravenously), meropenem (2 grams every 8 hours intravenously).

      Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline
      for 3 consecutive days. The standard arterial canula will be used to obtain samples.

      In each case CVVHD will be started and continued for at least 3 days' period. 30 minutes
      after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms.
      Subsequently, supernatant will be collected and frozen.

      Serum tigecycline concentration will be measured with high performance liquid chromatography.

      Each patient's hemodynamics parameters will be recorded with the use of transpulmonary
      thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an
      antifungal agent will be given as required.
observational model: Cohort
time perspective: Prospective
measure: Serum concentration of tigecycline
time frame: 72 hours for each patient from the tigecycline treatment initiation.
description: Samples obtain from ICU patients 2, 4, 8 12 hours after each dose of tigecycline for 3 days.
arm group label: tigecycline
description: Each patient will receive: tigecycline (200 mg q 12 hours i.v.), meropenem (2 g q 8 hours i.v). In each case CVVHD will be started.
Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline for 3 consecutive days.
Patients' arterial blood samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mirosław Czuczwar, M.D. PhD.
role: Principal Investigator
affiliation: Medical University of Lublin
last name: Michał A Borys, M.D., PhD.
phone: +48506350569
email: michalborys1@gmail.com
last name: Paweł Piwowarczyk, M.D.
phone: +48511285352
email: piwowarczyk.pawel@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lublin
investigator full name: Michał Borys
investigator title: associate professor
mesh term: Critical Illness
sharing ipd: No