The Impact Of A Catheter Coating On Clinical Bacteriuria

Not Applicable

Recruiting

• Conditions: Bacteriuria
• Interventions: Device: Camstent Coated Catheter; Device: Standard Care

• Registration Number: NCT04461262
• Lead Sponsor: Camstent Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-08
• Study Start: 2021-04-27
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-28
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Camstent Coated Catheter	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
Standard Care	Standard Care	Foley catheter, uncoated

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	1 Year	EQ-5D-5L questionnaire will be given to participants as well as a questionnaire asking participants on their experience using the catheter
Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls	1 Year

Trial Locations

Locations (4)

Norfolk & Norwich University Hospital; 🇬🇧 Norwich, United Kingdom

Stoke Mandeville Hospital; 🇬🇧 Buckingham, United Kingdom

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

Royal National Orthopaedic Hospital; 🇬🇧 London, United Kingdom