- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461262
The Impact Of A Catheter Coating On Clinical Bacteriuria
A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Prital Patel
- Phone Number: +447825757008
- Email: prital.patel@camstent.com
Study Locations
-
-
-
Buckingham, United Kingdom
- Recruiting
- Stoke Mandeville Hospital
-
Principal Investigator:
- Maurizo Belci
-
Cambridge, United Kingdom
- Recruiting
- Addenbrookes Hospital
-
Principal Investigator:
- Suzanne Biers
-
London, United Kingdom
- Recruiting
- Royal National Orthopaedic Hospital
-
Norwich, United Kingdom
- Recruiting
- Norfolk & Norwich University Hospital
-
Principal Investigator:
- Mark Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Camstent Coated Catheter
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
|
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
Other Names:
|
Other: Standard Care
Foley catheter, uncoated
|
Uncoated Foley catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls
Time Frame: 1 Year
|
1 Year
|
|
Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls
Time Frame: 1 Year
|
1 Year
|
|
Patient Reported Outcomes (PRO)
Time Frame: 1 Year
|
EQ-5D-5L questionnaire will be given to participants as well as a questionnaire asking participants on their experience using the catheter
|
1 Year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Prital Patel, Camstent Ltd.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cam-Cath-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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