<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/NCT01683760</url>
  </required_header>
  <id_info>
    <org_study_id>FLU_PK</org_study_id>
    <secondary_id>12172_231</secondary_id>
    <nct_id>NCT01683760</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study of Fluconazole in Premature Infants</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used&#xD;
      as prophylaxis of invasive fungal infection in premature infants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>drug level of fluconazole</measure>
    <time_frame>30min later, 10-12hr later, at routine lab with interval of 1week</time_frame>
    <description>four times drug level after 3th dose</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Very Low Birth Weight Infant</condition>
  <arm_group>
    <arm_group_label>Population PK</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluconazole</intervention_name>
    <description>Prophylactic fluconazole administration in VLBW infants</description>
    <arm_group_label>Population PK</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  very low birth weight infant (birth weight &lt; 1,500 g) who were admitted to the NICU&#xD;
             before day 3 of life&#xD;
&#xD;
          -  Informed consent from the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major congenital anomaly&#xD;
&#xD;
          -  Expired within 72 hours of life&#xD;
&#xD;
          -  Liver failure (AST or ALT levels with three times the upper limit of the range of&#xD;
             normal values or higher)&#xD;
&#xD;
          -  Proven congenital or intrauterine fungal infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>4 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Han-Suk Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Children's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Han-Suk Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Fluconazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
  </intervention_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/NCT01683760
org study id: FLU_PK
secondary id: 12172_231
nct id: NCT01683760
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used
      as prophylaxis of invasive fungal infection in premature infants.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: drug level of fluconazole
time frame: 30min later, 10-12hr later, at routine lab with interval of 1week
description: four times drug level after 3th dose
arm group label: Population PK
arm group type: Experimental
intervention type: Drug
intervention name: Fluconazole
description: Prophylactic fluconazole administration in VLBW infants
arm group label: Population PK
criteria: 
gender: All
minimum age: N/A
maximum age: 4 Weeks
healthy volunteers: No
last name: Han-Suk Kim, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Han-Suk Kim
investigator title: Professor
mesh term: Birth Weight
mesh term: Fluconazole