<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/NCT03040050</url>
  </required_header>
  <id_info>
    <org_study_id>16-386</org_study_id>
    <nct_id>NCT03040050</nct_id>
  </id_info>
  <brief_title>Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy</brief_title>
  <official_title>Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive&#xD;
      either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or&#xD;
      standard of care (control) prostate biopsy. The subjects will have a rectal culture swab&#xD;
      performed prior to the prostate biopsy. One rectal culture swab will be used for rapid&#xD;
      multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The&#xD;
      subjects randomized to the intervention group will have the qPCR results shared with the&#xD;
      physician to determine if additional standard of care antibiotics are needed at time of&#xD;
      standard of care prostate biopsy. The subjects randomized to the control group will not have&#xD;
      the qPCR results shared with the physician to determine if additional standard of care&#xD;
      antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days&#xD;
      after the prostate biopsy, the research staff will conduct a chart review and/or telephone&#xD;
      call to ask about any prostate biopsy infections and complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">July 2, 2019</completion_date>
  <primary_completion_date type="Actual">August 24, 2018</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>Double (Care Provider, Investigator)</masking>
    <masking_description>The rPCR results will be provided to the clinical provider for the Interventional group participants. The rPCR results will not be provided to the clinic provider for the control group participants.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.</measure>
    <time_frame>Day of prostate biopsy</time_frame>
    <description>Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine if rapid qPCR test results in longer patient wait times.</measure>
    <time_frame>Day of prostate biopsy</time_frame>
    <description>Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine if rPCR results and standard rectal culture results are the same.</measure>
    <time_frame>1 week</time_frame>
    <description>Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Antibiotic Therapy</condition>
  <condition>Prostate Biopsy</condition>
  <arm_group>
    <arm_group_label>Men scheduled for prostate biopsy randomized to Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Men scheduled for a prostate biopsy randomized to Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>rPCR results</intervention_name>
    <description>Interventional group: rPCR results will be shared with the clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care prostate biopsy.</description>
    <arm_group_label>Men scheduled for a prostate biopsy randomized to Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Control group: rPCR results will not be shared with the clinical provider at time of standard of care prostate biopsy. Standard of care antibiotic selection will be up to the discretion of the clinical provider.</description>
    <arm_group_label>Men scheduled for prostate biopsy randomized to Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be able to give informed consent&#xD;
&#xD;
          -  Be age 50 or older&#xD;
&#xD;
          -  Recommended to undergo a prostate biopsy&#xD;
&#xD;
          -  No allergy or side effect to fluoroquinolone antibiotics&#xD;
&#xD;
          -  No history of prostate biopsy infection&#xD;
&#xD;
          -  No hepatic or renal insufficiency in which fluoroquinolone antibiotics are&#xD;
             contraindicated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Age &lt; 50&#xD;
&#xD;
          -  Not recommended to have prostate biopsy&#xD;
&#xD;
          -  Allergic to or have side effects to fluoroquinolone antibiotics&#xD;
&#xD;
          -  History of prostate biopsy infection&#xD;
&#xD;
          -  Hepatic or renal insufficiency in which fluoroquinolones antibiotics are&#xD;
             contraindicated.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Liss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas Health Science Center San Antonio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Texas Veterans Health Care</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03040050
org study id: 16-386
nct id: NCT03040050
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study is a randomized controlled trial. Subjects are randomly assigned 1:1 to receive
      either rapid multiplex qPCR (intervention) prior to standard of care prostate biopsy or
      standard of care (control) prostate biopsy. The subjects will have a rectal culture swab
      performed prior to the prostate biopsy. One rectal culture swab will be used for rapid
      multiplex qPCR and the other swab will be sent to microbiology for a standard culture. The
      subjects randomized to the intervention group will have the qPCR results shared with the
      physician to determine if additional standard of care antibiotics are needed at time of
      standard of care prostate biopsy. The subjects randomized to the control group will not have
      the qPCR results shared with the physician to determine if additional standard of care
      antibiotics are needed at time of standard of care prostate biopsy. Approximately, 10 days
      after the prostate biopsy, the research staff will conduct a chart review and/or telephone
      call to ask about any prostate biopsy infections and complications.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Double (Care Provider, Investigator)
masking description: The rPCR results will be provided to the clinical provider for the Interventional group participants. The rPCR results will not be provided to the clinic provider for the control group participants.
measure: Results of rapid qPCR to determine standard of care antibiotic prophylaxis for prostate biopsy.
time frame: Day of prostate biopsy
description: Reduction in dual antibiotic prophylaxis in the intervention vs.usual care groups.
measure: Determine if rapid qPCR test results in longer patient wait times.
time frame: Day of prostate biopsy
description: Difference in the amount of time the PCR technique takes compared to the fastest workflow (physician chooses no additional antibiotics).
measure: Determine if rPCR results and standard rectal culture results are the same.
time frame: 1 week
description: Comparison of rPCR results to standard rectal culture on Fluoroquinolone infused MacConkey agar.
arm group label: Men scheduled for prostate biopsy randomized to Control
arm group type: Other
arm group label: Men scheduled for a prostate biopsy randomized to Intervention
arm group type: Experimental
intervention type: Other
intervention name: rPCR results
description: Interventional group: rPCR results will be shared with the clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care prostate biopsy.
arm group label: Men scheduled for a prostate biopsy randomized to Intervention
intervention type: Other
intervention name: Control group
description: Control group: rPCR results will not be shared with the clinical provider at time of standard of care prostate biopsy. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
arm group label: Men scheduled for prostate biopsy randomized to Control
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Liss, MD
role: Principal Investigator
affiliation: University of Texas Health Science Center San Antonio
facility: 
country: United States
responsible party type: Sponsor