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The Impact Of A Catheter Coating On Clinical Bacteriuria

Primary Purpose

Bacteriuria

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
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 prevention trial for Bacteriuria

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Stoke Mandeville HospitalRecruiting
  • Addenbrookes HospitalRecruiting
  • Royal National Orthopaedic HospitalRecruiting
  • Norfolk & Norwich University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

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. The device is CE marked

Foley catheter, uncoated

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
Patient Reported Outcomes (PRO)
EQ-5D-5L questionnaire will be given to participants as well as a questionnaire asking participants on their experience using the catheter

Full Information

First Posted
July 1, 2020
Last Updated
December 27, 2022
Sponsor
Camstent Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04461262
Brief Title
The Impact Of A Catheter Coating On Clinical Bacteriuria
Official Title
A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
October 2024 (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

5. Study Description

Brief Summary
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.

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Urine samples will not state which arm the participant is in
Allocation
Randomized
Enrollment
272 (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. The device is CE marked
Arm Title
Standard Care
Arm Type
Other
Arm Description
Foley catheter, uncoated
Intervention Type
Device
Intervention Name(s)
Camstent Coated Catheter
Other Intervention Name(s)
Standard Care
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. The device is CE marked
Intervention Type
Device
Intervention Name(s)
Standard Care
Intervention Description
Uncoated Foley catheter
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
Time Frame
1 Year
Title
Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
Time Frame
1 Year
Title
Patient Reported Outcomes (PRO)
Description
EQ-5D-5L questionnaire will be given to participants as well as a questionnaire asking participants on their experience using the catheter
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 catheter as a component of their routine clinical care as per hospital 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. 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
Phone
+447825757008
Email
prital.patel@camstent.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prital Patel
Organizational Affiliation
Camstent Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Stoke Mandeville Hospital
City
Buckingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizo Belci
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Biers
Facility Name
Royal National Orthopaedic Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Norfolk & Norwich University Hospital
City
Norwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Rochester

12. IPD Sharing Statement

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

Learn more about this trial

The Impact Of A Catheter Coating On Clinical Bacteriuria

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