The Impact Of A Catheter Coating On Clinical Bacteriuria

Bacteriuria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461262
• Other study ID #: Cam-Cath-001
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: October 2024

Study information

• Verified date: December 2022
• Source: Camstent Ltd.
• Contact: Prital Patel
• Phone: +447825757008
• Email: prital.patel[@]camstent.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteriuria

Intervention

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. The device is CE marked
• Standard Care
Uncoated Foley catheter

Locations

Country	Name	City	State
United Kingdom	Stoke Mandeville Hospital	Buckingham
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Royal National Orthopaedic Hospital	London
United Kingdom	Norfolk & Norwich University Hospital	Norwich

Sponsors (1)

Lead Sponsor	Collaborator
Camstent Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls		1 Year
Secondary	Change in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls		1 Year
Secondary	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

External Links

•   Camstent