<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/NCT03816384</url>
  </required_header>
  <id_info>
    <org_study_id>CRD-06-100548</org_study_id>
    <nct_id>NCT03816384</nct_id>
  </id_info>
  <brief_title>Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria</brief_title>
  <acronym>CAB</acronym>
  <official_title>Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Potrero Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Potrero Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial&#xD;
      infections in critically ill patients and are responsible for high morbidity rates, increased&#xD;
      hospital stays and associated costs.&#xD;
&#xD;
      The purpose of this study is to evaluate whether active drain line clearance by the Accuryn&#xD;
      Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring&#xD;
      catheters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary tract infection (UTI) is the most common healthcare associated infection (HAI)&#xD;
      acquired in hospitals and is estimated to account for approximately 13% of hospital&#xD;
      infections in the United States, of which 75% are associated with indwelling urinary&#xD;
      catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling&#xD;
      urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are&#xD;
      highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.&#xD;
&#xD;
      The purpose of this study is to evaluate whether active drain line clearance by the Accuryn&#xD;
      Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring&#xD;
      catheters for more than 72 hours. This study will also evaluate the efficacy in reducing&#xD;
      bacteriuria of the Accuryn silver fabricated silicone catheters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Declined to pursue Study due to anticipated low enrollment numbers&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 31, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2020</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>Parallel Assignment</intervention_model>
    <intervention_model_description>Multi-center, Randomized-Controlled-Trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in percentage of catheter-associated bacteriuria</measure>
    <time_frame>30 days</time_frame>
    <description>To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria</measure>
    <time_frame>30 days</time_frame>
    <description>To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Bacteriuria (ASB and CAUTI)</measure>
    <time_frame>30 days</time_frame>
    <description>To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine Culture Comparisons</measure>
    <time_frame>30 days</time_frame>
    <description>To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Critical Illness</condition>
  <condition>Burns</condition>
  <condition>Surgery</condition>
  <condition>Urinary Tract Infections</condition>
  <condition>Bacteriuria</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive Standard of Care, commercially available catheter utilized by hospital system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drain Line Clearance (DLC) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drain Line Clearance and Silver (DLCS) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of care urinary drainage system.</description>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DLC Group</intervention_name>
    <description>Urinary drainage system with active drain line clearance and plain silicone catheter.</description>
    <arm_group_label>Drain Line Clearance (DLC) Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DLCS Group</intervention_name>
    <description>Urinary drainage system with active drain line clearance and silver-doped silicone catheter.</description>
    <arm_group_label>Drain Line Clearance and Silver (DLCS) Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult (age ≥ 18)&#xD;
&#xD;
          2. Patient or Legally Authorized Representative (LAR) possess the capacity to provide&#xD;
             informed consent&#xD;
&#xD;
          3. Indication for a urinary bladder catheter (or one currently in place)&#xD;
&#xD;
          4. Expected urinary catheter requirement ≥ 72 hours&#xD;
&#xD;
          5. No current urinary tract infection&#xD;
&#xD;
          6. No current indication for prophylactic antibiotics. If a surgical patient, receive&#xD;
             perioperative antibiotics for no greater than 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to receive a urinary bladder catheter&#xD;
&#xD;
          2. Chronic suprapubic catheter in place&#xD;
&#xD;
          3. Expected survival &lt; 72 hours&#xD;
&#xD;
          4. Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic&#xD;
             antibiotics given at the time of surgery&#xD;
&#xD;
          5. Surgery of the genitourinary tract in the past 6 months prior to admission&#xD;
&#xD;
          6. Deemed unfit for the protocol by the investigator for any reason&#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>Kevin Foster, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maricopa Integrated Health System (MIHS)</affiliation>
  </overall_official>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 27, 2020</last_update_submitted>
  <last_update_submitted_qc>January 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urinary catheter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Bacteriuria</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03816384
org study id: CRD-06-100548
nct id: NCT03816384
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial
      infections in critically ill patients and are responsible for high morbidity rates, increased
      hospital stays and associated costs.

      The purpose of this study is to evaluate whether active drain line clearance by the Accuryn
      Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring
      catheters.
Urinary tract infection (UTI) is the most common healthcare associated infection (HAI)
      acquired in hospitals and is estimated to account for approximately 13% of hospital
      infections in the United States, of which 75% are associated with indwelling urinary
      catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling
      urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are
      highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.

      The purpose of this study is to evaluate whether active drain line clearance by the Accuryn
      Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring
      catheters for more than 72 hours. This study will also evaluate the efficacy in reducing
      bacteriuria of the Accuryn silver fabricated silicone catheters.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multi-center, Randomized-Controlled-Trial
primary purpose: Prevention
masking: None (Open Label)
measure: Difference in percentage of catheter-associated bacteriuria
time frame: 30 days
description: To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.
measure: Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
time frame: 30 days
description: To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
measure: Time to Bacteriuria (ASB and CAUTI)
time frame: 30 days
description: To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
measure: Urine Culture Comparisons
time frame: 30 days
description: To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).
arm group label: Standard of Care
arm group type: Active Comparator
description: Patients will receive Standard of Care, commercially available catheter utilized by hospital system.
arm group label: Drain Line Clearance (DLC) Group
arm group type: Experimental
description: Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.
arm group label: Drain Line Clearance and Silver (DLCS) Group
arm group type: Experimental
description: Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.
intervention type: Device
intervention name: Standard of Care
description: Standard of care urinary drainage system.
arm group label: Standard of Care
intervention type: Device
intervention name: DLC Group
description: Urinary drainage system with active drain line clearance and plain silicone catheter.
arm group label: Drain Line Clearance (DLC) Group
intervention type: Device
intervention name: DLCS Group
description: Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
arm group label: Drain Line Clearance and Silver (DLCS) Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin Foster, MD
role: Principal Investigator
affiliation: Maricopa Integrated Health System (MIHS)
responsible party type: Sponsor
mesh term: Urinary Tract Infections
mesh term: Bacteriuria
mesh term: Critical Illness
sharing ipd: No