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

NCT04658719 | Unknown DMC

• 1 other identifier: CAM-SPC-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacteriuria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• • 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

Study Arms (2)

Camstent Coated Catheter

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

Foley catheter, uncoated

Device: Standard Care

Interventions

Camstent Coated Catheter DEVICE

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.

Camstent Coated Catheter

Standard Care DEVICE

Uncoated Foley Catheter

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Camstent Ltd.: lead

Related Links

• Camstent

MeSH Terms

Conditions

Bacteriuria

Condition Hierarchy (Ancestors)

Urinary Tract Infections; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Prital Patel, MSc

CONTACT

+44 (0)333 987 4050; prital.patel@camstent.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 8, 2020
• Study Start: February 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share