xml: <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/NCT05964114</url>
    </required_header>
    <id_info>
      <org_study_id>7646</org_study_id>
      <nct_id>NCT05964114</nct_id>
    </id_info>
    <brief_title>First Time Right of Vancomycin</brief_title>
    <official_title>Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug&#xD;
        concentrations after continuous administration of the first vancomycin dose. Many beneficial&#xD;
        population pharmacokinetic (PPK) models are available however these are prevented from being&#xD;
        widely implemented in daily practice due to the complexity. The aim of this study is to&#xD;
        evaluate the effectiveness of individualized dosing with PPK models using a newly developed&#xD;
        user-friendly pharmacokinetic (PK) tool.&#xD;
  &#xD;
        In a preceding retrospective study, the percentage of patients within the target range after&#xD;
        initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO&#xD;
        patients) with calculated concentrations based on theoretical dose adjustments. In this study&#xD;
        we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours&#xD;
        after the start of treatment with individualized dosages based on (a combination) of&#xD;
        available PPK models in 134 adult ICU and orthopedic patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.</measure>
      <time_frame>two years</time_frame>
      <description>The percentage of patients with a vancomycin concentration within the therapeutic range (20-25 mg/L) in the first three days after start of treatment for standard of care (flat dose adjusted for renal function) versus MIPD dosing (starting dose determined using pharmacokinetic models).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">134</enrollment>
    <condition>Vancomycin</condition>
    <condition>Pharmacokinetics</condition>
    <arm_group>
      <arm_group_label>Starting dose of vancomycin standard vs MIPD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Comparison of vancomycin initial dosing via standard of care (flat dose adjusted for renal function) versus model informed precision dosing (starting dose adjusted using pharmacokinetic models).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vancomycin</intervention_name>
      <description>Initial dosing based on (a combinations of) pharmacokinetic models tailored to the individual patient. Dose adjustment starting dose (within registered dosing range).</description>
      <arm_group_label>Starting dose of vancomycin standard vs MIPD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic&#xD;
               department&#xD;
  &#xD;
            -  Patient or their legal representative is able and willing to sign the Informed Consent&#xD;
               Form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant woman&#xD;
  &#xD;
            -  Children&#xD;
  &#xD;
            -  Patients with a transplantation history&#xD;
  &#xD;
            -  Patients on continuous renal replacement therapy (CRRT)&#xD;
  &#xD;
            -  Patients receiving extracorporeal membrane oxygenation (ECMO)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>January 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Sebastiaan D.T. Sassen, PharmD PhD</investigator_full_name>
      <investigator_title>Pharmacometrician</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>
  
  
text: 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/NCT05964114
  org study id: 7646
  nct id: NCT05964114
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug
        concentrations after continuous administration of the first vancomycin dose. Many beneficial
        population pharmacokinetic (PPK) models are available however these are prevented from being
        widely implemented in daily practice due to the complexity. The aim of this study is to
        evaluate the effectiveness of individualized dosing with PPK models using a newly developed
        user-friendly pharmacokinetic (PK) tool.
  
        In a preceding retrospective study, the percentage of patients within the target range after
        initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO
        patients) with calculated concentrations based on theoretical dose adjustments. In this study
        we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours
        after the start of treatment with individualized dosages based on (a combination) of
        available PPK models in 134 adult ICU and orthopedic patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of patients within target range of vancomycin for standard treatment versus treatment using MIPD within the first three days of treatment.
  time frame: two years
  description: The percentage of patients with a vancomycin concentration within the therapeutic range (20-25 mg/L) in the first three days after start of treatment for standard of care (flat dose adjusted for renal function) versus MIPD dosing (starting dose determined using pharmacokinetic models).
  arm group label: Starting dose of vancomycin standard vs MIPD
  arm group type: Experimental
  description: Comparison of vancomycin initial dosing via standard of care (flat dose adjusted for renal function) versus model informed precision dosing (starting dose adjusted using pharmacokinetic models).
  intervention type: Drug
  intervention name: Vancomycin
  description: Initial dosing based on (a combinations of) pharmacokinetic models tailored to the individual patient. Dose adjustment starting dose (within registered dosing range).
  arm group label: Starting dose of vancomycin standard vs MIPD
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Sebastiaan D.T. Sassen, PharmD PhD
  investigator title: Pharmacometrician
  mesh term: Vancomycin