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

Bacteriuria Clinical Trial

— CAM-SPC-001  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658719
• Other study ID #: CAM-SPC-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Camstent Ltd.
• Contact: Prital Patel, MSc
• Phone: +44 (0)333 987 4050
• Email: prital.patel[@]camstent.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.
• Standard Care
Uncoated Foley Catheter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Camstent Ltd.

Outcome

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

External Links

•   Camstent