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A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria (CAM-SPC-001)

Primary Purpose

Bacteriuria

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Camstent Coated Catheter
Standard Care
Sponsored by
Camstent Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Bacteriuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Require insertion or exchange of a urinary catheter in a suprapubic position as a component of their routine clinical care as per guidelines
  • Patients aged 18+ years will be eligible for the study.
  • Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.

Exclusion Criteria:

  • Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.2. Patients that have asymptomatic infection (if required may need a blood test to confirm)
  • Pregnant or Breastfeeding.
  • Patients with a potentially immunocompromised conditions (HIV)
  • Has a known silicone allergy or sensitivity
  • Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
  • Any medication deemed by the Investigator to potentially interfere with the study treatment
  • Participation in any other clinical study.
  • Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Camstent Coated Catheter

    Standard Care

    Arm 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.

    Foley catheter, uncoated

    Outcomes

    Primary Outcome Measures

    The primary efficacy endpoint is a decrease in the number of days in which bacterial concentrations are greater than 105 CFU/mL in coated catheters, as compared to uncoated control catheters

    Secondary Outcome Measures

    • Patient Reported Outcomes (PRO)
    • Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
    • Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
    • Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls
    • Reduction in Biofilm
    • Reduction in site infection

    Full Information

    First Posted
    December 3, 2020
    Last Updated
    December 10, 2020
    Sponsor
    Camstent Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04658719
    Brief Title
    A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria
    Acronym
    CAM-SPC-001
    Official Title
    'A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria.'
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Camstent Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated 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 allocated to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacteriuria

    7. Study Design

    Primary Purpose
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Camstent Coated Catheter
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Standard Care
    Arm Type
    Active Comparator
    Arm Description
    Foley catheter, uncoated
    Intervention Type
    Device
    Intervention Name(s)
    Camstent Coated Catheter
    Intervention 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.
    Intervention Type
    Device
    Intervention Name(s)
    Standard Care
    Intervention Description
    Uncoated Foley Catheter
    Primary Outcome Measure Information:
    Title
    The primary efficacy endpoint is a decrease in the number of days in which bacterial concentrations are greater than 105 CFU/mL in coated catheters, as compared to uncoated control catheters
    Time Frame
    1 Year
    Secondary Outcome Measure Information:
    Title
    • Patient Reported Outcomes (PRO)
    Time Frame
    1 Year
    Title
    • Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
    Time Frame
    1 Year
    Title
    • Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
    Time Frame
    1 Year
    Title
    • Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls
    Time Frame
    1 Year
    Title
    • Reduction in Biofilm
    Time Frame
    1 Year
    Title
    • Reduction in site infection
    Time Frame
    1 Year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Require insertion or exchange of a urinary catheter in a suprapubic position as a component of their routine clinical care as per guidelines Patients aged 18+ years will be eligible for the study. Patient understands and is willing to participate in the study and is able to comply with study procedures and visits. Exclusion Criteria: Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.2. Patients that have asymptomatic infection (if required may need a blood test to confirm) Pregnant or Breastfeeding. Patients with a potentially immunocompromised conditions (HIV) Has a known silicone allergy or sensitivity Use of investigational drug or device within four weeks prior to study entry that may interfere with this study. Any medication deemed by the Investigator to potentially interfere with the study treatment Participation in any other clinical study. Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Prital Patel, MSc
    Phone
    +44 (0)333 987 4050
    Email
    prital.patel@camstent.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://camstent.com/
    Description
    Camstent

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    A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria

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