<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/NCT01720940</url>
  </required_header>
  <id_info>
    <org_study_id>NUHID-001</org_study_id>
    <nct_id>NCT01720940</nct_id>
  </id_info>
  <brief_title>Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin</brief_title>
  <official_title>Reducing Nephrotoxicity of Vancomycin: A Prospective, Randomized Study of Continuous Versus Intermittent Infusion of Vancomycin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tan Tock Seng Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National University Hospital, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being carried out to find out whether there is reduction in vancomycin-induced&#xD;
      kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous&#xD;
      infusion.&#xD;
&#xD;
      This study will recruit 220 subjects from 2 hospitals over a period of 3 years.&#xD;
&#xD;
      Participants are invited if they have an infection that requires prolonged vancomycin therapy&#xD;
      (&gt; more than 10 days).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>nephrotoxicity</measure>
    <time_frame>occurring any time while on vancomycin treatment up to 14 days post treatment completion</time_frame>
    <description>nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>biomarkers for detection of early nephrotoxicity</measure>
    <time_frame>measured weekly from the date of randomization until 14 days post completion of vancomycin</time_frame>
    <description>serum and urine NGAL and cystatin C</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Infections Requiring Prolonged Duration (&gt;10 Days) of Vancomycin</condition>
  <arm_group>
    <arm_group_label>continuous vancomycin infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>intermittent vancomycin infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vancomycin in this arm will be administered as intermittent infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>continuous vancomycin infusion</intervention_name>
    <description>24-hour continuous infusion of vancomycin</description>
    <arm_group_label>continuous vancomycin infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intermittent vancomycin infusion</intervention_name>
    <arm_group_label>intermittent vancomycin infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 21-80 years&#xD;
&#xD;
          -  Documented infection requiring prolonged (&gt; 10 days) of vancomycin therapy&#xD;
&#xD;
          -  Creatinine clearance &gt; 50 ml/min (using Cockroft-Gault equation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient already received 7 days or more of vancomycin therapy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe burns &gt; 40% body surface area&#xD;
&#xD;
          -  Spinal cord injuries&#xD;
&#xD;
          -  Participation in another interventional trial in previous 30 days&#xD;
&#xD;
          -  Inability to obtain informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shire Yang Tan</last_name>
    <phone>97989001</phone>
    <email>shire_yang_tan@nuhs.edu.sg</email>
  </overall_contact>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shire Yang Tan</last_name>
      <phone>97989001</phone>
      <email>shire_yang_tan@nuhs.edu.sg</email>
    </contact>
    <investigator>
      <last_name>Dale Fisher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>November 1, 2012</last_update_submitted>
  <last_update_submitted_qc>November 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University Hospital, Singapore</investigator_affiliation>
    <investigator_full_name>Medicine</investigator_full_name>
    <investigator_title>Division of Infectious Diseases</investigator_title>
  </responsible_party>
  <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/NCT01720940
org study id: NUHID-001
nct id: NCT01720940
lead sponsor: 
collaborator: 
has dmc: No
This study is being carried out to find out whether there is reduction in vancomycin-induced
      kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous
      infusion.

      This study will recruit 220 subjects from 2 hospitals over a period of 3 years.

      Participants are invited if they have an infection that requires prolonged vancomycin therapy
      (> more than 10 days).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: nephrotoxicity
time frame: occurring any time while on vancomycin treatment up to 14 days post treatment completion
description: nephrotoxicity as defined by the acute kidney injury network (AKIN) criteria using only serum creatinine criteria
measure: biomarkers for detection of early nephrotoxicity
time frame: measured weekly from the date of randomization until 14 days post completion of vancomycin
description: serum and urine NGAL and cystatin C
arm group label: continuous vancomycin infusion
arm group type: Experimental
arm group label: intermittent vancomycin infusion
arm group type: Active Comparator
description: vancomycin in this arm will be administered as intermittent infusion
intervention type: Drug
intervention name: continuous vancomycin infusion
description: 24-hour continuous infusion of vancomycin
arm group label: continuous vancomycin infusion
intervention type: Drug
intervention name: intermittent vancomycin infusion
arm group label: intermittent vancomycin infusion
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shire Yang Tan
phone: 97989001
email: shire_yang_tan@nuhs.edu.sg
facility: 
status: Recruiting
contact: 
investigator: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: National University Hospital, Singapore
investigator full name: Medicine
investigator title: Division of Infectious Diseases
mesh term: Vancomycin