<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/NCT03243864</url>
  </required_header>
  <id_info>
    <org_study_id>866</org_study_id>
    <nct_id>NCT03243864</nct_id>
  </id_info>
  <brief_title>Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis</brief_title>
  <official_title>: Pharmacokinetics of Ceftazidime-Avibactam in Critically Ill Patients With Renal Failure Requiring Continuous Venovenous Hemodiafiltration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study's primary objective is to determine plasma and dialysis fluid concentrations in&#xD;
      patients prescribed ceftazidime-avibactam as the standard treatment for their infection and&#xD;
      requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment&#xD;
      for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics&#xD;
      of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the&#xD;
      prescribed dose meets pharmacodynamic targets.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Anticipated">October 21, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 21, 2020</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>Ceftazidime plasma concentrations</measure>
    <time_frame>At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)</time_frame>
    <description>mg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Avibactam plasma concentrations</measure>
    <time_frame>At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)</time_frame>
    <description>mg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ceftazidime effluent concentrations</measure>
    <time_frame>At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)</time_frame>
    <description>mg/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Avibactam effluent concentrations</measure>
    <time_frame>At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)</time_frame>
    <description>mg/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)</time_frame>
    <description>mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse effects as a measure of safety</measure>
    <time_frame>Days 1-30</time_frame>
    <description>Measure of safety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum plasma concentration (Cmin)</measure>
    <time_frame>At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)</time_frame>
    <description>mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (t1/2)</measure>
    <time_frame>8-hours</time_frame>
    <description>hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (Cl)</measure>
    <time_frame>8-hours</time_frame>
    <description>L/hr</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC 0 to 8 hours</measure>
    <time_frame>8-hours</time_frame>
    <description>mg*hr/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sieving Coefficient</measure>
    <time_frame>8-hours</time_frame>
    <description>SC</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Renal Failure</condition>
  <condition>Bacterial Infections</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Ceftazidime and Avibactam</arm_group_label>
    <description>Ceftazidime-avibactam pharmacokinetic monitoring</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftazidime-avibactam</intervention_name>
    <description>Patients will be started on 2.5 gm IV every 8 hours</description>
    <arm_group_label>Ceftazidime and Avibactam</arm_group_label>
    <other_name>Avycaz</other_name>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, plasma, effluent fluid from dialysis machine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Hospitalized patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults &gt; 18 years of age&#xD;
&#xD;
          -  Patients requiring continuous renal replacement therapy (CRRT) due to acute or chronic&#xD;
             renal failure&#xD;
&#xD;
          -  documented or suspected infection requiring a prescription for ceftazidime-avibactam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients on CRRT &lt; 24 hours&#xD;
&#xD;
          -  Patients on ceftazidime-avibactam &lt; 24 hours&#xD;
&#xD;
          -  Patients unable to remain on CRRT for 32 hours continuously without clotting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Rose, Pharm.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christina Rose, Pharm.D.</last_name>
    <phone>215-707-8057</phone>
    <email>rosecm@temple.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniel Mueller, MD</last_name>
    <phone>215-707-1982</phone>
    <email>Daniel.Mueller2@tuhs.temple.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christina Rose, Pharm.D.</last_name>
      <phone>215-707-8057</phone>
      <email>rosecm@temple.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacterial Infections</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ceftazidime</mesh_term>
    <mesh_term>Avibactam</mesh_term>
    <mesh_term>Avibactam, ceftazidime drug combination</mesh_term>
  </intervention_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/NCT03243864
org study id: 866
nct id: NCT03243864
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The study's primary objective is to determine plasma and dialysis fluid concentrations in
      patients prescribed ceftazidime-avibactam as the standard treatment for their infection and
      requiring continuous venovenous hemodiafiltration (CVVHDF) as part of the standard treatment
      for acute or chronic renal failure. Secondarily, the study will evaluate the pharmacokinetics
      of ceftazidime-avibactam in these patients on CVVHDF. The study will also determine if the
      prescribed dose meets pharmacodynamic targets.
observational model: Case-Only
time perspective: Prospective
measure: Ceftazidime plasma concentrations
time frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
description: mg/L
measure: Avibactam plasma concentrations
time frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
description: mg/L
measure: Ceftazidime effluent concentrations
time frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
description: mg/L
measure: Avibactam effluent concentrations
time frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
description: mg/L
measure: Maximum plasma concentration (Cmax)
time frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
description: mg/L
measure: Number of participants with adverse effects as a measure of safety
time frame: Days 1-30
description: Measure of safety
measure: Minimum plasma concentration (Cmin)
time frame: At hours post dose: 0, 2, 3, 4, 6, 8 on or after Day 2 of therapy (i.e. during the fourth dose)
description: mg/L
measure: Half-life (t1/2)
time frame: 8-hours
description: hours
measure: Clearance (Cl)
time frame: 8-hours
description: L/hr
measure: AUC 0 to 8 hours
time frame: 8-hours
description: mg*hr/L
measure: Sieving Coefficient
time frame: 8-hours
description: SC
arm group label: Ceftazidime and Avibactam
description: Ceftazidime-avibactam pharmacokinetic monitoring
intervention type: Drug
intervention name: Ceftazidime-avibactam
description: Patients will be started on 2.5 gm IV every 8 hours
arm group label: Ceftazidime and Avibactam
other name: Avycaz
Whole blood, plasma, effluent fluid from dialysis machine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christina Rose, Pharm.D.
role: Principal Investigator
affiliation: Temple University
last name: Christina Rose, Pharm.D.
phone: 215-707-8057
email: rosecm@temple.edu
last name: Daniel Mueller, MD
phone: 215-707-1982
email: Daniel.Mueller2@tuhs.temple.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Bacterial Infections
mesh term: Renal Insufficiency
mesh term: Critical Illness
mesh term: Ceftazidime
mesh term: Avibactam
mesh term: Avibactam, ceftazidime drug combination
sharing ipd: No