<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/NCT04461262</url>
  </required_header>
  <id_info>
    <org_study_id>Cam-Cath-001</org_study_id>
    <nct_id>NCT04461262</nct_id>
  </id_info>
  <brief_title>The Impact Of A Catheter Coating On Clinical Bacteriuria</brief_title>
  <official_title>A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Camstent Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Camstent Ltd.</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>
      A prospective multicentre randomized study to assess the impact of a catheter coating on&#xD;
      clinical bacteriuria when compared to an uncoated foley catheter.&#xD;
&#xD;
      Each participant will take part in the trial from the time the participant signs the informed&#xD;
      consent form (ICF).&#xD;
&#xD;
      After the screening visit, the participants will be randomized to either a coated catheter or&#xD;
      an uncoated catheter. Participants will be assigned to receive trial treatment until the&#xD;
      catheter has been removed as per standard hospital guidelines, investigator's decision to&#xD;
      withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse&#xD;
      event, or participant withdraws consent.&#xD;
&#xD;
      During the trial urine samples will be taken form the catheter port, temperature will be&#xD;
      taken, and participants and healthcare providers will be asked to complete questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 27, 2021</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</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>Single (Outcomes Assessor)</masking>
    <masking_description>Urine samples will not state which arm the participant is in</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of days in which bacterial concentrations are greater than 10^5 CFU/mL in coated catheters, as compared to uncoated control catheters</measure>
    <time_frame>1 Year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes (PRO)</measure>
    <time_frame>1 Year</time_frame>
    <description>EQ-5D-5L questionnaire will be given to participants as well as a questionnaire asking participants on their experience using the catheter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">272</enrollment>
  <condition>Bacteriuria</condition>
  <arm_group>
    <arm_group_label>Camstent Coated Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Foley catheter, uncoated</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Camstent Coated Catheter</intervention_name>
    <description>The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked</description>
    <arm_group_label>Camstent Coated Catheter</arm_group_label>
    <other_name>Standard Care</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Uncoated Foley catheter</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Require insertion or exchange of a catheter as a component of their routine clinical&#xD;
             care as per hospital guidelines&#xD;
&#xD;
          2. Patients aged 18+ years will be eligible for the study.&#xD;
&#xD;
          3. Patient understands and is willing to participate in the study and is able to comply&#xD;
             with study procedures and visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients that have or recently (within 3 weeks) had a urinary catheter and displays&#xD;
             symptoms of current urinary tract infection.&#xD;
&#xD;
          2. Pregnant or Breastfeeding.&#xD;
&#xD;
          3. Patients with a potentially immunocompromised conditions (HIV)&#xD;
&#xD;
          4. Has a known silicone allergy or sensitivity&#xD;
&#xD;
          5. Use of investigational drug or device within four weeks prior to study entry that may&#xD;
             interfere with this study.&#xD;
&#xD;
          6. Any medication deemed by the Investigator to potentially interfere with the study&#xD;
             treatment&#xD;
&#xD;
          7. Participation in any other clinical study.&#xD;
&#xD;
          8. Has a known bloodstream infection or an infection that requires prolonged antibiotic&#xD;
             therapy&#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>Prital Patel</last_name>
    <role>Study Director</role>
    <affiliation>Camstent Ltd.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Prital Patel</last_name>
    <phone>+447825757008</phone>
    <email>prital.patel@camstent.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stoke Mandeville Hospital</name>
      <address>
        <city>Buckingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maurizo Belci</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Addenbrookes Hospital</name>
      <address>
        <city>Cambridge</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Suzanne Biers</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal National Orthopaedic Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Norfolk &amp; Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mark Rochester</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://camstent.com/</url>
    <description>Camstent</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>December 27, 2022</last_update_submitted>
  <last_update_submitted_qc>December 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</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>Bacteriuria</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/NCT04461262
org study id: Cam-Cath-001
nct id: NCT04461262
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A prospective multicentre randomized study to assess the impact of a catheter coating on
      clinical bacteriuria when compared to an uncoated foley catheter.

      Each participant will take part in the trial from the time the participant signs the informed
      consent form (ICF).

      After the screening visit, the participants will be randomized to either a coated catheter or
      an uncoated catheter. Participants will be assigned to receive trial treatment until the
      catheter has been removed as per standard hospital guidelines, investigator's decision to
      withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse
      event, or participant withdraws consent.

      During the trial urine samples will be taken form the catheter port, temperature will be
      taken, and participants and healthcare providers will be asked to complete questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Urine samples will not state which arm the participant is in
measure: Change in the number of days in which bacterial concentrations are greater than 10^5 CFU/mL in coated catheters, as compared to uncoated control catheters
time frame: 1 Year
measure: Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
time frame: 1 Year
measure: Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
time frame: 1 Year
measure: Patient Reported Outcomes (PRO)
time frame: 1 Year
description: EQ-5D-5L questionnaire will be given to participants as well as a questionnaire asking participants on their experience using the catheter
arm group label: Camstent Coated Catheter
arm group type: Experimental
description: The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked
arm group label: Standard Care
arm group type: Other
description: Foley catheter, uncoated
intervention type: Device
intervention name: Camstent Coated Catheter
description: The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked
arm group label: Camstent Coated Catheter
other name: Standard Care
intervention type: Device
intervention name: Standard Care
description: Uncoated Foley catheter
arm group label: Standard Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prital Patel
role: Study Director
affiliation: Camstent Ltd.
last name: Prital Patel
phone: +447825757008
email: prital.patel@camstent.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
investigator: 
country: United Kingdom
url: http://camstent.com/
description: Camstent
responsible party type: Sponsor
mesh term: Bacteriuria
sharing ipd: No