<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/NCT02210169</url>
  </required_header>
  <id_info>
    <org_study_id>Vanc_IIV vs CIV</org_study_id>
    <nct_id>NCT02210169</nct_id>
  </id_info>
  <brief_title>RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates</brief_title>
  <official_title>A Randomised Controlled Trial (RCT) of Continuous and Intermittent Infusion of Vancomycin in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Murdoch Childrens Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Hospital For Women</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Murdoch Childrens Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will&#xD;
      be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over&#xD;
      1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering&#xD;
      vancomycin as a continuous infusion will result in improved attainment of target&#xD;
      concentrations in blood at steady state (when the drug is in equilibrium) compared to&#xD;
      intermittent infusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drug-related adverse effects</measure>
    <time_frame>2 years</time_frame>
    <description>the proportion of drug-related adverse effects with CIV compared to IIV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to achieve target levels</measure>
    <time_frame>2 years</time_frame>
    <description>the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance of vancomycin in young infants</measure>
    <time_frame>2 years</time_frame>
    <description>Population pharmacokinetic modelling of vancomycin in young infants using NONMEM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution of vancomycin in young infants</measure>
    <time_frame>2 years</time_frame>
    <description>Population pharmacodynamics modelling of vancomycin in young infants using NONMEM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve of vancomycin in young infants</measure>
    <time_frame>2 years</time_frame>
    <description>Population pharmacodynamics modelling of vancomycin in young infants using NONMEM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants</measure>
    <time_frame>2 years</time_frame>
    <description>Population pharmacodynamics modelling of vancomycin in young infants using NONMEM</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Sepsis</condition>
  <condition>Infection</condition>
  <condition>Bacteremia</condition>
  <arm_group>
    <arm_group_label>Intermittent infusion of vancomycin</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous infusion of vancomycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Continuous infusion of vancomycin</intervention_name>
    <description>Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.</description>
    <arm_group_label>Continuous infusion of vancomycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Neonates in the neonatal unit with an infection requiring treatment with vancomycin as&#xD;
        determined by the treating physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with a corrected gestational age &lt; 25 weeks.&#xD;
&#xD;
          -  Allergy to vancomycin or other glycopeptide antibiotic&#xD;
&#xD;
          -  Vancomycin administered within the previous 72 hours&#xD;
&#xD;
          -  Renal impairment&#xD;
&#xD;
          -  Prior enrolment in the study&#xD;
&#xD;
          -  Need for drug that is incompatible with vancomycin (if no other IV line is available)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>90 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amanda Gwee, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Murdoch Children's Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Hospital for Women</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Children's Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>October 31, 2018</last_update_submitted>
  <last_update_submitted_qc>October 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</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>Bacteremia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</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/NCT02210169
org study id: Vanc_IIV vs CIV
nct id: NCT02210169
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Babies aged 0 to 90 days with a suspected infection requiring treatment with vancomycin will
      be recruited. They will be randomised to receive vancomycin as an intermittent infusion (over
      1 hour) or as a continuous infusion (over 24 hours). The hypothesis is that administering
      vancomycin as a continuous infusion will result in improved attainment of target
      concentrations in blood at steady state (when the drug is in equilibrium) compared to
      intermittent infusion.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of neonates achieving target vancomycin concentrations in blood at steady state (24-48 hours)
time frame: 2 years
measure: Drug-related adverse effects
time frame: 2 years
description: the proportion of drug-related adverse effects with CIV compared to IIV
measure: Time to achieve target levels
time frame: 2 years
description: the time to and number of dose adjustments required to achieve target therapeutic vancomycin levels in blood
measure: Clearance of vancomycin in young infants
time frame: 2 years
description: Population pharmacokinetic modelling of vancomycin in young infants using NONMEM
measure: Volume of distribution of vancomycin in young infants
time frame: 2 years
description: Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
measure: Area under the concentration-time curve of vancomycin in young infants
time frame: 2 years
description: Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
measure: Time above the minimum inhibitory concentration of the bacteria for vancomycin in young infants
time frame: 2 years
description: Population pharmacodynamics modelling of vancomycin in young infants using NONMEM
arm group label: Intermittent infusion of vancomycin
arm group type: No Intervention
description: Vancomycin will be administered intravenously over 1 hour. Doses will be given from one to four times a day according to corrected gestational age.
arm group label: Continuous infusion of vancomycin
arm group type: Active Comparator
description: A loading dose of vancomycin will be given over 1 hour followed by a continuous infusion of vancomycin over a 24 hour period.
intervention type: Drug
intervention name: Continuous infusion of vancomycin
description: Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.
arm group label: Continuous infusion of vancomycin
criteria: 
gender: All
minimum age: N/A
maximum age: 90 Days
healthy volunteers: No
last name: Amanda Gwee, MBBS
role: Principal Investigator
affiliation: Murdoch Children's Research Institute
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Bacteremia
mesh term: Vancomycin