The Impact Of A Catheter Coating On Clinical Bacteriuria

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Multicentre Randomized Study To Assess The Impact Of A Catheter Coating On Clinical Bacteriuria

Conditions
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Bacteriuria

Intervention / Treatment
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* Device: Camstent Coated Catheter
* Device: Standard Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Camstent Coated Catheter<br>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 | Device: Camstent Coated Catheter<br>* 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<br>* Other names: Standard Care;|
| Other: Standard Care<br>Foley catheter, uncoated | Device: Standard Care<br>* Uncoated Foley catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 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 |  | 1 Year | 
| Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls |  | 1 Year | 
| 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 | 1 Year |