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

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

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.

Study Overview

• Status: Unknown
• Conditions: Bacteriuria
• Intervention / Treatment: Device: Camstent Coated Catheter; Device: Standard Care

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prital Patel, MSc; Phone Number: +44 (0)333 987 4050; Email: prital.patel@camstent.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	Device: 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.
Active Comparator: Standard Care; Foley catheter, uncoated	Device: Standard Care; Uncoated Foley Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
• Patient Reported Outcomes (PRO)	1 Year
• Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls	1 Year
• Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls	1 Year
• Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls	1 Year
• Reduction in Biofilm	1 Year
• Reduction in site infection	1 Year

Collaborators and Investigators

• Sponsor: Camstent Ltd.

Publications and helpful links

Helpful Links

• Camstent

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Urinary Tract Infections; Bacteriuria
• Other Study ID Numbers: CAM-SPC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No