Characterisation of Biofilm Growth on Coated vs. Uncoated Urinary Catheter Surfaces in Normal Clinical Use

NCT05513677 | Completed

• 1 other identifier: PRO30CSP
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

• 20 who receive the M4D coated catheter.
• 10 who receive the standard uncoated catheters used in routine patient care.

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the percentage of catheter surface colonised by biofilm, calculated as (light / (light + dark) x 100% in measurement of stained samples using fluorescence microscopy.

  The primary outcome is the percentage of catheter surface colonised by biofilm, calculated as (light / (light + dark) x 100% in measurement of stained samples using fluorescence microscopy.

  30 days

Secondary Outcomes (1)

• Secondary outcomes will be logging of events, including catheter blockage or presumed CAUTI.

  30days

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of Care

Device: Standard of Care

M4D coated catheter

EXPERIMENTAL

Experimental

Device: M4D

Interventions

M4D DEVICE

Coated catheter

M4D coated catheter

Standard of Care DEVICE

Standard of Care

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients under age 18.
• Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection.
• Patients who they have had previous radiation therapy in lower pelvis.
• Patients who are cognitively impaired, or are unwilling to give consent
• Patients with a potentially immunocompromised condition
• Patients that require further antibiotics after initial dose, or those that are administered antibiotics following an infection whilst the trial urinary catheter is in situ

Sponsors & Collaborators

• Camstent Ltd.: lead

Study Sites (1)

The James Cook University Hospital,

Middlesbrough, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1. Evaluated Patients: 5 patients (Convenience sample: non-blinded, non-randomised) Selection follows documented hospital protocols for routine catheterisation 2. Measured Patients: 30 patients (Convenience sample: non-blinded and non-randomised) * 20 who receive the M4D coated catheter. * 10 who receive the standard uncoated catheters used in routine patient care.

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: August 14, 2018
• Primary Completion: May 20, 2020
• Study Completion: December 30, 2021
• Last Updated: August 31, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)