<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/NCT02198833</url>
  </required_header>
  <id_info>
    <org_study_id>SC120028</org_study_id>
    <secondary_id>H-32673</secondary_id>
    <nct_id>NCT02198833</nct_id>
  </id_info>
  <brief_title>Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection</brief_title>
  <official_title>Clinical Study to Assess the Efficacy of a Novel Micro-Patterned Foley Catheter to Reduce Catheter-Associated UrinaryTract Infection Among Spinal Cord Injury Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the study Foley catheter with its patterned&#xD;
      external surface can delay the time to the onset of urinary tract infection in spinal cord&#xD;
      injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Roughly half of the two million nosocomial infections that occur each year are associated&#xD;
      with the use of a medical device. Approximately 30 million urinary catheters are inserted&#xD;
      each year into the bladder of over five million patients, and each catheterized patient is at&#xD;
      risk of developing catheter-associated symptomatic urinary tract infection. About 95% of&#xD;
      urinary tract infections are associated with the use of a urinary catheter. Not only is&#xD;
      catheter associated urinary tract infection the most common nosocomial infection in general,&#xD;
      but it is also the most common infectious reason for admission to the hospital among the&#xD;
      population of 275 thousand Americans with spinal cord injury, which expands by approximately&#xD;
      12 thousand persons each year. Hospital-acquired infections boost today's healthcare costs by&#xD;
      billions of dollars and healthcare providers are increasingly responsible for shouldering&#xD;
      these costs.&#xD;
&#xD;
      Catheter-associated symptomatic urinary tract infection is usually caused by organisms that&#xD;
      originate from the patient's own colonic and perineal flora, or the hands of healthcare&#xD;
      personnel during catheter insertion and manipulation of the collection system. Microbial&#xD;
      species predominantly migrate into the bladder extraluminally via the mucoid film that forms&#xD;
      between the catheter surface and the urethra. Current approaches for preventing&#xD;
      catheter-related infections include antimicrobial modification of the catheter surface.&#xD;
      Although these antimicrobial-based catheters aim to eradicate bacteria residing in the&#xD;
      vicinity of the catheter surface, they can result in antibiotic resistance, which could have&#xD;
      serious implications on patient care.&#xD;
&#xD;
      A novel urinary catheter, the Micro-Patterned Foley catheter has been developed that&#xD;
      incorporates a micro-pattern texture on the surface; the texture is too small to see or feel,&#xD;
      but has demonstrated an impressive effect in the laboratory inhibiting microbial attachment&#xD;
      to the surface and microbial migration along the micro-patterned catheter segments. The&#xD;
      objective of the study is to determine whether the novel Micro-Patterned catheter can delay&#xD;
      the onset of catheter associated urinary tract infection in catheterized spinal cord injured&#xD;
      patients. If successful, this catheter will help improve quality of patient care and reduce&#xD;
      cost of care by reducing the need for antibiotic treatment. This finding could extend to&#xD;
      other patient populations that require urinary catheterization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study catheter manufacturing issues. Poor enrollment.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection</measure>
    <time_frame>15 Days</time_frame>
    <description>Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Occurrence of Asymptomatic Bacteruria or Funguria</measure>
    <time_frame>15 days</time_frame>
    <description>Urine cultures will be obtained every third day to assess for the presence of microbial growth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the Microbial Coverage and Biofilm Formation on Catheter Surface</measure>
    <time_frame>Day 15 or upon removal of Foley Catheter</time_frame>
    <description>Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Specific Adverse Event Assessments</measure>
    <time_frame>15 Days</time_frame>
    <description>Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Urinary Tract Infection</condition>
  <arm_group>
    <arm_group_label>Micro-Patterned Foley Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard-of-Care Foley Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Urine Culture</intervention_name>
    <description>Obtain urine culture every third day</description>
    <arm_group_label>Micro-Patterned Foley Catheter</arm_group_label>
    <arm_group_label>Standard-of-Care Foley Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Foley Catheter Tip Culture</intervention_name>
    <description>Catheter Tip Roll Plate Culture</description>
    <arm_group_label>Micro-Patterned Foley Catheter</arm_group_label>
    <arm_group_label>Standard-of-Care Foley Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Scanning Electron Microscopy</intervention_name>
    <description>Houston Site Only</description>
    <arm_group_label>Micro-Patterned Foley Catheter</arm_group_label>
    <arm_group_label>Standard-of-Care Foley Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Device Specific Adverse Event Assessment</intervention_name>
    <description>Assessment will be made of catheter patency and/or trauma related to catheter placement</description>
    <arm_group_label>Micro-Patterned Foley Catheter</arm_group_label>
    <arm_group_label>Standard-of-Care Foley Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Foley Catheter Insertion</intervention_name>
    <description>Insert Foley catheter for 15 day duration</description>
    <arm_group_label>Micro-Patterned Foley Catheter</arm_group_label>
    <arm_group_label>Standard-of-Care Foley Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Veteran&#xD;
&#xD;
          -  Hospitalized in one of the two participating Spinal Cord Injury Units&#xD;
&#xD;
          -  Require a size 14, 16, or 18 French catheter&#xD;
&#xD;
          -  Sign and date the written informed consent document acknowledging his/her desire to&#xD;
             participate in the study, or if unable to sign due to spinal cord injury give verbal&#xD;
             consent in front of two impartial witnesses who sign and date the informed consent&#xD;
             document in the presence of the participant&#xD;
&#xD;
          -  Be able to understand and comply with written and verbal protocol requirements,&#xD;
             instructions, and protocol-stated restrictions&#xD;
&#xD;
          -  Require insertion or exchange of a Foley catheter for no longer than 15 days.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Has a current symptomatic urinary tract infection&#xD;
&#xD;
          -  Has persistent bacteriuria that cannot be cleared with antimicrobial agents to a&#xD;
             nominal level of less than 1,000 Colony Forming Units/mL prior to study catheter&#xD;
             insertion&#xD;
&#xD;
          -  Has a known bloodstream infection or an infection that requires prolonged antibiotic&#xD;
             therapy&#xD;
&#xD;
          -  Has periurethral inflammation or infection&#xD;
&#xD;
          -  Has a known urethral anatomical anomaly which makes catheterization difficult&#xD;
&#xD;
          -  Has a known silicone allergy or sensitivity&#xD;
&#xD;
          -  Cannot accommodate a size 14,16 or 18 French Foley catheter.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rabih O Darouiche, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>James A. Haley Veterans' Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael E. DeBakey Veterans Affairs Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <results_first_submitted>February 1, 2017</results_first_submitted>
  <results_first_submitted_qc>April 5, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2017</results_first_posted>
  <last_update_submitted>April 5, 2017</last_update_submitted>
  <last_update_submitted_qc>April 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Rabih Darouiche</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>Urinary Tract Infection</keyword>
  <keyword>Bacteriuria</keyword>
  <keyword>Transurethral Foley Catheter</keyword>
  <keyword>Suprapubic Foley Catheter</keyword>
  <keyword>Spinal Cord injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Number of patients entered in the study is too small for analysis of data.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Micro-Patterned Foley Catheter</title>
          <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
        </group>
        <group group_id="P2">
          <title>Standard-of-Care Foley Catheter</title>
          <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1">Unable to clear urine of bacteria for all but one patient therefore catheter not placed</participants>
                <participants group_id="P2" count="1">Unable to clear urine of bacteria for all but one patient therefore catheter not placed.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>No analysis completed due to inability to place study catheter in all but two patients due to inability to clear urine of bacteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Micro-Patterned Foley Catheter</title>
          <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
        </group>
        <group group_id="B2">
          <title>Standard-of-Care Foley Catheter</title>
          <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection</title>
        <description>Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.</description>
        <time_frame>15 Days</time_frame>
        <population>No analysis completed due to inability to place study catheter due to persistent bacterial colonization.</population>
        <group_list>
          <group group_id="O1">
            <title>Micro-Patterned Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
          <group group_id="O2">
            <title>Standard-of-Care Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
        </group_list>
        <measure>
          <title>Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection</title>
          <description>Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.</description>
          <population>No analysis completed due to inability to place study catheter due to persistent bacterial colonization.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Occurrence of Asymptomatic Bacteruria or Funguria</title>
        <description>Urine cultures will be obtained every third day to assess for the presence of microbial growth.</description>
        <time_frame>15 days</time_frame>
        <population>No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Micro-Patterned Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
          <group group_id="O2">
            <title>Standard-of-Care Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Occurrence of Asymptomatic Bacteruria or Funguria</title>
          <description>Urine cultures will be obtained every third day to assess for the presence of microbial growth.</description>
          <population>No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assess the Microbial Coverage and Biofilm Formation on Catheter Surface</title>
        <description>Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.</description>
        <time_frame>Day 15 or upon removal of Foley Catheter</time_frame>
        <population>No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Micro-Patterned Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
          <group group_id="O2">
            <title>Standard-of-Care Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
        </group_list>
        <measure>
          <title>Assess the Microbial Coverage and Biofilm Formation on Catheter Surface</title>
          <description>Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.</description>
          <population>No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Device Specific Adverse Event Assessments</title>
        <description>Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.</description>
        <time_frame>15 Days</time_frame>
        <population>No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Micro-Patterned Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
          <group group_id="O2">
            <title>Standard-of-Care Foley Catheter</title>
            <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
          </group>
        </group_list>
        <measure>
          <title>Device Specific Adverse Event Assessments</title>
          <description>Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.</description>
          <population>No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Patients were monitored for adverse events for a one month period.</time_frame>
      <desc>Definitions of adverse events planned for use in this study did not differ from those of clinicaltrials.gov.</desc>
      <group_list>
        <group group_id="E1">
          <title>Micro-Patterned Foley Catheter</title>
          <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
        </group>
        <group group_id="E2">
          <title>Standard-of-Care Foley Catheter</title>
          <description>Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy&#xD;
Urine Culture: Obtain urine culture every third day&#xD;
Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture&#xD;
Scanning Electron Microscopy: Houston Site Only&#xD;
Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement&#xD;
Foley Catheter Insertion: Insert Foley catheter for 15 day duration</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Two major factors: 1) Production of the study catheter took much longer than expected. Only size 16 French Foley available; and 2) The inability to clear asymptomatic bacteriuria from patients' urinary bladder prior to study catheter placement.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Rabih Darouiche, MD</name_or_title>
      <organization>Baylor College of Medcine</organization>
      <phone>713-794-8858</phone>
      <email>rabihd@bcm.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02198833
org study id: SC120028
secondary id: H-32673
nct id: NCT02198833
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if the study Foley catheter with its patterned
      external surface can delay the time to the onset of urinary tract infection in spinal cord
      injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.
Roughly half of the two million nosocomial infections that occur each year are associated
      with the use of a medical device. Approximately 30 million urinary catheters are inserted
      each year into the bladder of over five million patients, and each catheterized patient is at
      risk of developing catheter-associated symptomatic urinary tract infection. About 95% of
      urinary tract infections are associated with the use of a urinary catheter. Not only is
      catheter associated urinary tract infection the most common nosocomial infection in general,
      but it is also the most common infectious reason for admission to the hospital among the
      population of 275 thousand Americans with spinal cord injury, which expands by approximately
      12 thousand persons each year. Hospital-acquired infections boost today's healthcare costs by
      billions of dollars and healthcare providers are increasingly responsible for shouldering
      these costs.

      Catheter-associated symptomatic urinary tract infection is usually caused by organisms that
      originate from the patient's own colonic and perineal flora, or the hands of healthcare
      personnel during catheter insertion and manipulation of the collection system. Microbial
      species predominantly migrate into the bladder extraluminally via the mucoid film that forms
      between the catheter surface and the urethra. Current approaches for preventing
      catheter-related infections include antimicrobial modification of the catheter surface.
      Although these antimicrobial-based catheters aim to eradicate bacteria residing in the
      vicinity of the catheter surface, they can result in antibiotic resistance, which could have
      serious implications on patient care.

      A novel urinary catheter, the Micro-Patterned Foley catheter has been developed that
      incorporates a micro-pattern texture on the surface; the texture is too small to see or feel,
      but has demonstrated an impressive effect in the laboratory inhibiting microbial attachment
      to the surface and microbial migration along the micro-patterned catheter segments. The
      objective of the study is to determine whether the novel Micro-Patterned catheter can delay
      the onset of catheter associated urinary tract infection in catheterized spinal cord injured
      patients. If successful, this catheter will help improve quality of patient care and reduce
      cost of care by reducing the need for antibiotic treatment. This finding could extend to
      other patient populations that require urinary catheterization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection
time frame: 15 Days
description: Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.
measure: Time to Occurrence of Asymptomatic Bacteruria or Funguria
time frame: 15 days
description: Urine cultures will be obtained every third day to assess for the presence of microbial growth.
measure: Assess the Microbial Coverage and Biofilm Formation on Catheter Surface
time frame: Day 15 or upon removal of Foley Catheter
description: Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.
measure: Device Specific Adverse Event Assessments
time frame: 15 Days
description: Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.
arm group label: Micro-Patterned Foley Catheter
arm group type: Experimental
description: Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
arm group label: Standard-of-Care Foley Catheter
arm group type: Active Comparator
description: Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
intervention type: Biological
intervention name: Urine Culture
description: Obtain urine culture every third day
arm group label: Micro-Patterned Foley Catheter
arm group label: Standard-of-Care Foley Catheter
intervention type: Device
intervention name: Foley Catheter Tip Culture
description: Catheter Tip Roll Plate Culture
arm group label: Micro-Patterned Foley Catheter
arm group label: Standard-of-Care Foley Catheter
intervention type: Device
intervention name: Scanning Electron Microscopy
description: Houston Site Only
arm group label: Micro-Patterned Foley Catheter
arm group label: Standard-of-Care Foley Catheter
intervention type: Procedure
intervention name: Device Specific Adverse Event Assessment
description: Assessment will be made of catheter patency and/or trauma related to catheter placement
arm group label: Micro-Patterned Foley Catheter
arm group label: Standard-of-Care Foley Catheter
intervention type: Procedure
intervention name: Foley Catheter Insertion
description: Insert Foley catheter for 15 day duration
arm group label: Micro-Patterned Foley Catheter
arm group label: Standard-of-Care Foley Catheter
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rabih O Darouiche, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Rabih Darouiche
investigator title: Physician
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
sharing ipd: No
ipd description: Number of patients entered in the study is too small for analysis of data.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Two major factors: 1) Production of the study catheter took much longer than expected. Only size 16 French Foley available; and 2) The inability to clear asymptomatic bacteriuria from patients' urinary bladder prior to study catheter placement.
point of contact: 