<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/NCT01661361</url>
  </required_header>
  <id_info>
    <org_study_id>S54585</org_study_id>
    <nct_id>NCT01661361</nct_id>
  </id_info>
  <brief_title>Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices</brief_title>
  <official_title>Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, it was reported that when vancomycin levels are determined after port sampling,&#xD;
      levels can be falsely increased potentially leading to wrong dose adjustments.&#xD;
&#xD;
      The investigators conducted an in vitro experiment using several central venous port devices,&#xD;
      in which different flushing techniques were evaluated yielding residual vancomycin levels of&#xD;
      less than 0.5 mg/L.&#xD;
&#xD;
      In this study, the investigators want to evaluate this flushing technique in vivo in 15&#xD;
      patients admitted with catheter-related infection and treated with systemic vancomycin and&#xD;
      vancomycin antibiotic lock.&#xD;
&#xD;
      The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained&#xD;
      via port sampling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L</measure>
    <time_frame>central and peripheral vancomycin levels will be obtained during steady state: this means starting from the 4th dose (= day 2) of vancomycin treatment. Vancomycin is usually given during 14 days after the last positive blood culture.</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Catheter-related Infection</condition>
  <arm_group>
    <arm_group_label>vancomycin cohort</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood levels</intervention_name>
    <arm_group_label>vancomycin cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted for catheter related infection with methicillin-resistant&#xD;
        coagulase-negative staphylococci (MR-CNS) and treated with systemic vancomycin in&#xD;
        combination with vancomycin antibiotic lock via central venous port device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients,&#xD;
&#xD;
          -  having central venous port device,&#xD;
&#xD;
          -  treated with systemic vancomycin in combination with vancomycin antibiotic lock&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women,&#xD;
&#xD;
          -  children,&#xD;
&#xD;
          -  patients with 'do not resuscitate' (DNR) code&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabel Spriet, PharmD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pharmacy Dpt, University Hospitals Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jan Verhaegen, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical Diagnostic Sciences, University Hospitals Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans Prenen, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Digestive ONcology, University Hosptials Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Willy Peetermans, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Internal Medicine, University Hospitals Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ludo Willems, PharmD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Pharmacy Dpt., University Hosptials Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Isabel Spriet, PharmD PhD</last_name>
    <phone>0032 16 34 30 80</phone>
    <email>isabel.spriet@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jan Verhaegen, MD PhD</last_name>
    <phone>0032 16 33 22 11</phone>
    <email>jan.verhaegen@uzleuven.be</email>
  </overall_contact_backup>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 8, 2012</last_update_submitted>
  <last_update_submitted_qc>August 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Isabelle Spriet</investigator_full_name>
    <investigator_title>PharmD, PhD</investigator_title>
  </responsible_party>
  <keyword>vancomycin</keyword>
  <keyword>levels</keyword>
  <keyword>central venous port device</keyword>
  <keyword>peripherally obtained levels</keyword>
  <keyword>dose adjustments</keyword>
  <keyword>TDM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Catheter-Related Infections</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/NCT01661361
org study id: S54585
nct id: NCT01661361
lead sponsor: 
has dmc: No
Recently, it was reported that when vancomycin levels are determined after port sampling,
      levels can be falsely increased potentially leading to wrong dose adjustments.

      The investigators conducted an in vitro experiment using several central venous port devices,
      in which different flushing techniques were evaluated yielding residual vancomycin levels of
      less than 0.5 mg/L.

      In this study, the investigators want to evaluate this flushing technique in vivo in 15
      patients admitted with catheter-related infection and treated with systemic vancomycin and
      vancomycin antibiotic lock.

      The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained
      via port sampling.
observational model: Cohort
time perspective: Prospective
measure: comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L
time frame: central and peripheral vancomycin levels will be obtained during steady state: this means starting from the 4th dose (= day 2) of vancomycin treatment. Vancomycin is usually given during 14 days after the last positive blood culture.
arm group label: vancomycin cohort
intervention type: Procedure
intervention name: blood levels
arm group label: vancomycin cohort
blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabel Spriet, PharmD PhD
role: Principal Investigator
affiliation: Pharmacy Dpt, University Hospitals Leuven
last name: Jan Verhaegen, MD PhD
role: Study Chair
affiliation: Medical Diagnostic Sciences, University Hospitals Leuven
last name: Hans Prenen, MD PhD
role: Study Chair
affiliation: Digestive ONcology, University Hosptials Leuven
last name: Willy Peetermans, MD PhD
role: Study Chair
affiliation: Internal Medicine, University Hospitals Leuven
last name: Ludo Willems, PharmD PhD
role: Study Chair
affiliation: Pharmacy Dpt., University Hosptials Leuven
last name: Isabel Spriet, PharmD PhD
phone: 0032 16 34 30 80
email: isabel.spriet@uzleuven.be
last name: Jan Verhaegen, MD PhD
phone: 0032 16 33 22 11
email: jan.verhaegen@uzleuven.be
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Isabelle Spriet
investigator title: PharmD, PhD
mesh term: Catheter-Related Infections