<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/NCT01716988</url>
  </required_header>
  <id_info>
    <org_study_id>NL39246.042.12</org_study_id>
    <nct_id>NCT01716988</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Micafungin in Critically Ill Patients</brief_title>
  <official_title>Pharmacokinetics of Micafungin in Critically Ill Patients With Invasive Candidiasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment&#xD;
      success in ICU patients compared with non-ICU patients. It is known that in critically ill&#xD;
      patients, alterations in function of various organs and body systems can influence the&#xD;
      pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters&#xD;
      of micafungin in critically ill patients are most likely different, but this has not been&#xD;
      specifically studied.&#xD;
&#xD;
      The pharmacokinetic parameters of micafungin in critically ill patients will be established&#xD;
      and plasma concentrations of micafungin will be correlated with disease severity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.</measure>
    <time_frame>4 days</time_frame>
    <description>Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters of micafungin in ICU patients.</measure>
    <time_frame>4 days</time_frame>
    <description>Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (in days) to culture conversion.</measure>
    <time_frame>max 28 days</time_frame>
    <description>Number of days untill cultures are negative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the plasma concentration of micafungin with response to treatment.</measure>
    <time_frame>max 28 days</time_frame>
    <description>Correlation of the level of micafungin concentration with outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of the plasma concentration of micafungin with inflammation parameters.</measure>
    <time_frame>4 days</time_frame>
    <description>Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.</measure>
    <time_frame>max 28 days</time_frame>
    <description>Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composing a pharmacokinetic model of micafungin in critically ill patients.</measure>
    <time_frame>max 28 days</time_frame>
    <description>Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio.</measure>
    <time_frame>28 days</time_frame>
    <description>Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Critical Illness</condition>
  <condition>Invasive Candidiasis</condition>
  <arm_group>
    <arm_group_label>Micafungin</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with invasive candidiasis admitted to an intensive care unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Treatment with micafungin.&#xD;
&#xD;
          -  Admission to an ICU.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Invasive candidiasis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood sampling not possible.&#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>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700 RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Jan-Willem C Alffenaar</investigator_full_name>
    <investigator_title>PharmD, PhD</investigator_title>
  </responsible_party>
  <keyword>Micafungin</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>invasive candidiasis</keyword>
  <keyword>intensive care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Candidiasis, Invasive</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- 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/NCT01716988
org study id: NL39246.042.12
nct id: NCT01716988
lead sponsor: 
has dmc: No
A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment
      success in ICU patients compared with non-ICU patients. It is known that in critically ill
      patients, alterations in function of various organs and body systems can influence the
      pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters
      of micafungin in critically ill patients are most likely different, but this has not been
      specifically studied.

      The pharmacokinetic parameters of micafungin in critically ill patients will be established
      and plasma concentrations of micafungin will be correlated with disease severity.
observational model: Case-Only
time perspective: Prospective
measure: Correlation of pharmacokinetic parameters/plasma concentrations of micafungin with disease severity.
time frame: 4 days
description: Correlation of the level of micafungin concentration with disease severity scores. Correlation of pharmacokinetic parameters (clearance, half-life) of micafungin with disease severity scores.
measure: Pharmacokinetic parameters of micafungin in ICU patients.
time frame: 4 days
description: Calculate the pharmacokinetic parameters (clearance, half life, volume of distribution) of micafungin.
measure: Time (in days) to culture conversion.
time frame: max 28 days
description: Number of days untill cultures are negative.
measure: Correlation of the plasma concentration of micafungin with response to treatment.
time frame: max 28 days
description: Correlation of the level of micafungin concentration with outcome.
measure: Correlation of the plasma concentration of micafungin with inflammation parameters.
time frame: 4 days
description: Correlation of the level of micafungin concentration with interleukin-6, interleukin-8 and procalcitonin.
measure: Area under the concentration-time curve (AUC)/minimal inhibitory concentration (MIC) ratio.
time frame: max 28 days
description: Area under the concentration-time curve of micafungin devided by the minimal inhibitory concentration of the candida species.
measure: Composing a pharmacokinetic model of micafungin in critically ill patients.
time frame: max 28 days
description: Composing a pharmacokinetic model of micafungin to estimate the 24-hours AUC of micafungin based on limited samples.
measure: Highest observed plasma concentration (Cmax)/minimal inhibitory concentration (MIC) ratio.
time frame: 28 days
description: Highest observed plasma concentration of micafungin devided by the minimal inhibitory concentration of the candida species.
arm group label: Micafungin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Jan-Willem C Alffenaar
investigator title: PharmD, PhD
mesh term: Candidiasis
mesh term: Candidiasis, Invasive
mesh term: Critical Illness