<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/NCT04404855</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20190678H</org_study_id>
    <nct_id>NCT04404855</nct_id>
  </id_info>
  <brief_title>Antibiotic Selection Using Next Generation Sequencing vs Urine Culture</brief_title>
  <acronym>ACCESS</acronym>
  <official_title>Antibiotic Selection Using Next Generation Sequencing (NGS) Versus Urine Culture for Stewardship Prior to Surgery Using an Interprofessional Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MicroGen DX</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled clinical study evaluating the use of next-generation&#xD;
      sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous&#xD;
      nephrolithotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NGS will be performed on voided urine collected as routine care approximately 30 days prior&#xD;
      to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to&#xD;
      help select the most appropriate antibiotics, and independently as part of routine care,&#xD;
      surgeons will choose the antibiotic that they would use in each case, while the Infectious&#xD;
      Disease pharmacists would select their optimum choice. Approximately 220 subjects will be&#xD;
      randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard&#xD;
      of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will&#xD;
      have urine cultures sent for analysis, and the physician will choose antibiotics based on&#xD;
      results as per usual practice. Subjects assigned to the NGS group, in addition to routine&#xD;
      urine culture results, will have NGS urine culture results sent to an investigational drrug&#xD;
      (ID) pharmacist, and recommendations will be shared with the physician to determine the&#xD;
      antibiotic selection. The physician will ultimately decide the appropriate antibiotics to&#xD;
      prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone&#xD;
      call to ask about any post-operative infections, complications, and any additional&#xD;
      antibiotics that were prescribed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 18, 2019</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of infection post surgery</measure>
    <time_frame>One to two weeks after surgery</time_frame>
    <description>Number of participants that develop post surgical infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of antibiotics selected for participants</measure>
    <time_frame>Within 30 days of urine culture and date of surgery</time_frame>
    <description>The number of antibiotics or the number of classes of antibiotics prescribed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Kidney Stone</condition>
  <condition>Renal Stone</condition>
  <condition>Infection, Bacterial</condition>
  <arm_group>
    <arm_group_label>Intervention Group (NGS + Antibiotic Recommendation)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NGS + Antibiotic Recommendation</intervention_name>
    <description>NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist</description>
    <arm_group_label>Intervention Group (NGS + Antibiotic Recommendation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard of Care treatment</intervention_name>
    <description>Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients planning to undergo kidney or bladder stone removal surgery using endoscopy&#xD;
             including ureteroscopy and percutaneous nephrolithotomy or any other transurethral&#xD;
             procedure&#xD;
&#xD;
          -  Age 18 or older&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to provide informed consent&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Does not meet inclusion criteria&#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>Michael Liss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Health at San Antonio</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Liss, MD</last_name>
    <phone>210-567-5676</phone>
    <email>liss@uthscsa.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Hudson, BS</last_name>
    <phone>210-450-8688</phone>
    <email>hudsonr1@uthscsa.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Audie Murphy VA Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Liss, MD</last_name>
      <phone>210-567-5640</phone>
      <email>liss@uthscsa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Molly Doris</last_name>
      <phone>210-567-1172</phone>
      <email>doris@uthscsa.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Liss, MD</last_name>
      <phone>210-567-5676</phone>
      <email>Liss@uthscsa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Molly Doris, BS</last_name>
      <phone>210-567-1172</phone>
      <email>doris@uthscsa.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Michael Liss, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Health System</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Liss, MD</last_name>
      <phone>210-567-5640</phone>
      <email>liss@uthscsa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Molly Doris</last_name>
      <phone>210-567-1172</phone>
      <email>doris@uthscsa.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</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>Bacterial Infections</mesh_term>
    <mesh_term>Kidney Calculi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>September 1, 2022</submitted>
    <returned>July 25, 2023</returned>
    <submitted>August 17, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04404855
org study id: HSC20190678H
nct id: NCT04404855
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled clinical study evaluating the use of next-generation
      sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous
      nephrolithotomy.
NGS will be performed on voided urine collected as routine care approximately 30 days prior
      to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to
      help select the most appropriate antibiotics, and independently as part of routine care,
      surgeons will choose the antibiotic that they would use in each case, while the Infectious
      Disease pharmacists would select their optimum choice. Approximately 220 subjects will be
      randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard
      of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will
      have urine cultures sent for analysis, and the physician will choose antibiotics based on
      results as per usual practice. Subjects assigned to the NGS group, in addition to routine
      urine culture results, will have NGS urine culture results sent to an investigational drrug
      (ID) pharmacist, and recommendations will be shared with the physician to determine the
      antibiotic selection. The physician will ultimately decide the appropriate antibiotics to
      prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone
      call to ask about any post-operative infections, complications, and any additional
      antibiotics that were prescribed.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of infection post surgery
time frame: One to two weeks after surgery
description: Number of participants that develop post surgical infection
measure: Number of antibiotics selected for participants
time frame: Within 30 days of urine culture and date of surgery
description: The number of antibiotics or the number of classes of antibiotics prescribed
arm group label: Intervention Group (NGS + Antibiotic Recommendation)
arm group type: Other
description: Next Generation Sequencing results along with Infectious Disease Pharmacist will be shared with clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
arm group label: Control Group
arm group type: Other
description: NGS results will not be shared with the clinical provider at time of standard of care urology stone procedure. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
intervention type: Other
intervention name: NGS + Antibiotic Recommendation
description: NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
arm group label: Intervention Group (NGS + Antibiotic Recommendation)
intervention type: Procedure
intervention name: Standard of Care treatment
description: Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Liss, MD
role: Principal Investigator
affiliation: University of Texas Health at San Antonio
last name: Michael Liss, MD
phone: 210-567-5676
email: liss@uthscsa.edu
last name: Robert Hudson, BS
phone: 210-450-8688
email: hudsonr1@uthscsa.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Bacterial Infections
mesh term: Kidney Calculi
mesh term: Anti-Bacterial Agents
submitted: September 1, 2022
returned: July 25, 2023
submitted: August 17, 2023