<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/NCT02993575</url>
  </required_header>
  <id_info>
    <org_study_id>UMCN-AKF-16.08</org_study_id>
    <nct_id>NCT02993575</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion to ICU Patients</brief_title>
  <acronym>FANATIC</acronym>
  <official_title>Pharmacokinetics of Flucloxacillin Given by Continuous or Intermittent Infusion as Therapy to Patients With an Infection in the Intensive Care Unit (ICU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canisius-Wilhelmina Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rijnstate Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tergooi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gelderse Vallei Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared&#xD;
      to non-ICU patients. The investigators will determine total and free flucloxacillin&#xD;
      concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion&#xD;
      (n=20) of flucloxacillin as standard care.&#xD;
&#xD;
      Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing&#xD;
      regimen and limited sampling will be taken for individual patients on the continuous dosing&#xD;
      regimen on day 2 and 4.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared&#xD;
      to non-ICU patients. There is a substantial risk that present standard dosing regimens of&#xD;
      antibiotics lead to suboptimal outcomes for patients on the ICU. To prevent the risk of&#xD;
      inadequate dosing in critically ill patients, it is important to optimize dosing regimens in&#xD;
      ICU patients.&#xD;
&#xD;
      With this study the investigators will define pharmacokinetics of flucloxacillin in ICU&#xD;
      patients and search for variables influencing pharmacokinetics. By using population modeling&#xD;
      the investigators will simulate different dosing regimens, intermittent and continuous, and&#xD;
      compare probability of target attainment between continuous and intermittent infusion.&#xD;
&#xD;
      To be able to include 30 patients within the study duration, a multi-centre approach is&#xD;
      necessary.&#xD;
&#xD;
      Patients will receive standard care, as stated in the product characteristics or according to&#xD;
      local protocols. Minimally invasive blood sampling for pharmacokinetic analysis will be&#xD;
      retrieved through a central venous catheter or an arterial line. Full pharmacokinetic curves&#xD;
      will be taken for individual patients on the intermittent dosing regimen and limited sampling&#xD;
      will be taken for individual patients on the continuous dosing regimen on day 2 and 4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</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>Clearance</measure>
    <time_frame>Day 2 and 4</time_frame>
    <description>Full pharmacokinetic curves will be taken on Day 2 and Day 4</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Bacterial Infections</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flucloxacillin</intervention_name>
    <description>Dose according to summary of product characteristics (SPC) or local protocols: intermittent and continuous infusion</description>
    <other_name>Floxapen</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples for determination of total flucloxacillin and free flucloxacillin&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients receiving flucloxacillin for treating a suspected or proven bacterial&#xD;
        infection at the ICU will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is admitted to an ICU&#xD;
&#xD;
          2. Subject is at least 18 years old on the day of the first dosing&#xD;
&#xD;
          3. Is managed with a central venous catheter or arterial line&#xD;
&#xD;
          4. Patient is treated with flucloxacillin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Has previously participated in this trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Flucloxacillin</keyword>
  <keyword>Continuous infusion</keyword>
  <keyword>Intensive Care Unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Floxacillin</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/NCT02993575
org study id: UMCN-AKF-16.08
nct id: NCT02993575
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared
      to non-ICU patients. The investigators will determine total and free flucloxacillin
      concentrations in 30 ICU patients, who will get continuous (n=10) or intermittent infusion
      (n=20) of flucloxacillin as standard care.

      Full pharmacokinetic curves will be taken for individual patients on the intermittent dosing
      regimen and limited sampling will be taken for individual patients on the continuous dosing
      regimen on day 2 and 4.
The pharmacokinetics of flucloxacillin are expected to be different in ICU patients compared
      to non-ICU patients. There is a substantial risk that present standard dosing regimens of
      antibiotics lead to suboptimal outcomes for patients on the ICU. To prevent the risk of
      inadequate dosing in critically ill patients, it is important to optimize dosing regimens in
      ICU patients.

      With this study the investigators will define pharmacokinetics of flucloxacillin in ICU
      patients and search for variables influencing pharmacokinetics. By using population modeling
      the investigators will simulate different dosing regimens, intermittent and continuous, and
      compare probability of target attainment between continuous and intermittent infusion.

      To be able to include 30 patients within the study duration, a multi-centre approach is
      necessary.

      Patients will receive standard care, as stated in the product characteristics or according to
      local protocols. Minimally invasive blood sampling for pharmacokinetic analysis will be
      retrieved through a central venous catheter or an arterial line. Full pharmacokinetic curves
      will be taken for individual patients on the intermittent dosing regimen and limited sampling
      will be taken for individual patients on the continuous dosing regimen on day 2 and 4.
observational model: Case-Only
time perspective: Prospective
measure: Clearance
time frame: Day 2 and 4
description: Full pharmacokinetic curves will be taken on Day 2 and Day 4
intervention type: Drug
intervention name: Flucloxacillin
description: Dose according to summary of product characteristics (SPC) or local protocols: intermittent and continuous infusion
other name: Floxapen
Plasma samples for determination of total flucloxacillin and free flucloxacillin
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Infections
mesh term: Bacterial Infections
mesh term: Floxacillin
sharing ipd: No