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/NCT06005168</url>
    </required_header>
    <id_info>
      <org_study_id>HUM00222771</org_study_id>
      <secondary_id>R01HS027183</secondary_id>
      <nct_id>NCT06005168</nct_id>
    </id_info>
    <brief_title>Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis</brief_title>
    <acronym>MorphAbxPKSurg</acronym>
    <official_title>Comparison of a Morphomic-Based to the Standard-of-Care-Based Cefazolin Dose for Antimicrobial Prophylaxis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Michigan</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</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>
        The goal of this clinical study is to compare the dosing of an antibiotic in overweight&#xD;
        patients having surgery. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Are the antibiotic concentrations in blood and fat tissue in patients that are&#xD;
             overweight sufficient to prevent the chance of infection?&#xD;
  &#xD;
          -  Can dosing using body composition rather than body weight improve the chance of&#xD;
             achieving good antibiotic concentrations in overweight patients? Participants will allow&#xD;
             us to collect small amounts of blood and fat tissue during their regularly scheduled&#xD;
             surgery.&#xD;
  &#xD;
        Researchers will compare differences in antibiotic concentrations based on dosing by standard&#xD;
        of care (body weight based) versus body composition.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The risk of surgical site infections are higher in patients with obesity compared to&#xD;
        non-obese adults. Our group has previously demonstrated that radiologic measures of abdominal&#xD;
        subcutaneous fat are associated with surgical site infection risk in patients undergoing&#xD;
        colorectal surgeries, which could reflect suboptimal antibiotic exposure in these patients.&#xD;
        Therefore, we hypothesized that measures of abdominal size and composition in patients&#xD;
        undergoing colorectal surgery would be more predictive of antimicrobial pharmacokinetics in&#xD;
        this tissue compartment than the current standards of body weight and BMI. We confirmed this&#xD;
        hypothesis and identified kidney function and body depth (by morphomics) to be predictive of&#xD;
        cefazolin exposure in target tissue. Morphomics is a technology that transforms existing&#xD;
        computed tomography data into body measures and composition. This study is a head-to-head&#xD;
        comparison of this new proposed morphomic test regimen to the standard of care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 8, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>Phase 4</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>
      <intervention_model_description>The current model for dosing the drug cefazolin includes the selection of 2 grams if the individual weighs less than 120 kg and 3 grams if they weigh 120 kg or more. The morphomic-based model defined the choice of 2 grams versus 3 grams of cefazolin based on kidney function and body depth.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>This is open label</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of Concentration Target Attainment</measure>
      <time_frame>4 hours</time_frame>
      <description>Proportion of patients achieving at least 3.2 hours of time above 2 mcg/mL (MIC90) in subcutaneous fat tissue with the standard of care compared to morphomic-based dosing</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cefazolin exposure based on body depth</measure>
      <time_frame>4 hours</time_frame>
      <description>Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with a body depth above and below 350 mm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cefazolin exposure based on kidney function</measure>
      <time_frame>4 hours</time_frame>
      <description>Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with an estimated creatinine clearance above and below 120 mL/min</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">104</enrollment>
    <condition>Surgical Prophylaxis</condition>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The patients assigned to this group have cefazolin dose assignments based on body weight, which is the standard of care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Morphomic-based</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients assigned to this group have cefazolin dose assignments based on body depth and kidney function.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cefazolin for Injection</intervention_name>
      <description>2 grams or 3 grams based on standard of care or morphomic-based decision</description>
      <arm_group_label>Morphomic-based</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Accessible abdominal computed tomography scan prior to surgery&#xD;
  &#xD;
            2. Adult patients &gt; 18 years of age&#xD;
  &#xD;
            3. Body Mass Index ≥ 25 kg/m^2&#xD;
  &#xD;
            4. Expected to receive cefazolin prior to surgical incision&#xD;
  &#xD;
            5. Estimated creatinine clearance ≥90 mL/min&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of a hypersensitivity reaction to penicillin or cephalosporin&#xD;
  &#xD;
            2. Pregnancy&#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_contact>
      <last_name>Amit P Pai, PharmD</last_name>
      <phone>7346470006</phone>
      <email>amitpai@umich.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>June Sullivan, MBA</last_name>
      <phone>734-615-3488</phone>
      <email>jusulli@med.umich.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Michigan Hospital</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48108</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amit P Pai, PharmD</last_name>
        <phone>734-647-0006</phone>
        <email>amitpai@umich.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Michigan</investigator_affiliation>
      <investigator_full_name>Stewart Wang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Surgical Prophylaxis</keyword>
    <keyword>Pharmacokinetics</keyword>
    <keyword>Cefazolin</keyword>
    <keyword>Obesity</keyword>
    <keyword>Morphomics</keyword>
    <keyword>Colorectal</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cefazolin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06005168
  org study id: HUM00222771
  secondary id: R01HS027183
  nct id: NCT06005168
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this clinical study is to compare the dosing of an antibiotic in overweight
        patients having surgery. The main question[s] it aims to answer are:
  
          -  Are the antibiotic concentrations in blood and fat tissue in patients that are
             overweight sufficient to prevent the chance of infection?
  
          -  Can dosing using body composition rather than body weight improve the chance of
             achieving good antibiotic concentrations in overweight patients? Participants will allow
             us to collect small amounts of blood and fat tissue during their regularly scheduled
             surgery.
  
        Researchers will compare differences in antibiotic concentrations based on dosing by standard
        of care (body weight based) versus body composition.
  The risk of surgical site infections are higher in patients with obesity compared to
        non-obese adults. Our group has previously demonstrated that radiologic measures of abdominal
        subcutaneous fat are associated with surgical site infection risk in patients undergoing
        colorectal surgeries, which could reflect suboptimal antibiotic exposure in these patients.
        Therefore, we hypothesized that measures of abdominal size and composition in patients
        undergoing colorectal surgery would be more predictive of antimicrobial pharmacokinetics in
        this tissue compartment than the current standards of body weight and BMI. We confirmed this
        hypothesis and identified kidney function and body depth (by morphomics) to be predictive of
        cefazolin exposure in target tissue. Morphomics is a technology that transforms existing
        computed tomography data into body measures and composition. This study is a head-to-head
        comparison of this new proposed morphomic test regimen to the standard of care.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The current model for dosing the drug cefazolin includes the selection of 2 grams if the individual weighs less than 120 kg and 3 grams if they weigh 120 kg or more. The morphomic-based model defined the choice of 2 grams versus 3 grams of cefazolin based on kidney function and body depth.
  primary purpose: Other
  masking: None (Open Label)
  masking description: This is open label
  measure: Proportion of Concentration Target Attainment
  time frame: 4 hours
  description: Proportion of patients achieving at least 3.2 hours of time above 2 mcg/mL (MIC90) in subcutaneous fat tissue with the standard of care compared to morphomic-based dosing
  measure: Cefazolin exposure based on body depth
  time frame: 4 hours
  description: Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with a body depth above and below 350 mm
  measure: Cefazolin exposure based on kidney function
  time frame: 4 hours
  description: Compare the area under the curve from time 0 to 4 hours (AUC0-4) in plasma and subcutaneous fat in patients with an estimated creatinine clearance above and below 120 mL/min
  arm group label: Standard of Care
  arm group type: No Intervention
  description: The patients assigned to this group have cefazolin dose assignments based on body weight, which is the standard of care.
  arm group label: Morphomic-based
  arm group type: Active Comparator
  description: The patients assigned to this group have cefazolin dose assignments based on body depth and kidney function.
  intervention type: Drug
  intervention name: Cefazolin for Injection
  description: 2 grams or 3 grams based on standard of care or morphomic-based decision
  arm group label: Morphomic-based
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amit P Pai, PharmD
  phone: 7346470006
  email: amitpai@umich.edu
  last name: June Sullivan, MBA
  phone: 734-615-3488
  email: jusulli@med.umich.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Michigan
  investigator full name: Stewart Wang
  investigator title: Professor
  mesh term: Cefazolin
  sharing ipd: No