NCT02669342

Brief Summary

The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

January 20, 2016

Last Update Submit

April 4, 2017

Conditions

Urinary CatheterUrinary Tract Infections

Keywords

InfectionUrinary CatheterSharklet

Outcome Measures

Primary Outcomes (2)

  • Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)

    Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.

    12 weeks

  • Number of symptomatic Urinary tract infections (UTIs) determined by urine culture

    Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.

    12 weeks

Secondary Outcomes (7)

  • Delay to symptomatic CA-SUTI

    12 weeks

  • Incidence of bacteria

    12 weeks

  • Incidence of Crustation

    12 weeks

  • Incidence of Discomfort

    12 weeks

  • Surface analysis of the type of bacteria found on each catheter

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group A: Sharklet Catheter for 2 weeks first

ACTIVE COMPARATOR

Arm A will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 2 weeks 2. Standard catheter inserted for 2 weeks 3. Sharklet catheter inserted for 4 weeks 4. Standard catheter inserted for 4 weeks

Device: Radiance™ Clear Sharklet® Silicone Foley CatheterDevice: Silicone Foley Catheter

Group B: Sharklet Catheter for 4 weeks first

ACTIVE COMPARATOR

Arm B will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 4 weeks 2. Standard catheter inserted for 4 weeks 3. Sharklet catheter inserted for 2 weeks 4. Standard catheter inserted for 2 weeks

Device: Radiance™ Clear Sharklet® Silicone Foley CatheterDevice: Silicone Foley Catheter

Interventions

Radiance™ Clear Sharklet® Silicone Foley CatheterDEVICE
Group A: Sharklet Catheter for 2 weeks firstGroup B: Sharklet Catheter for 4 weeks first
Silicone Foley CatheterDEVICE
Also known as: Standard of care
Group A: Sharklet Catheter for 2 weeks firstGroup B: Sharklet Catheter for 4 weeks first

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient requires a chronic indwelling Foley catheter for at least 14 days. Catheters will not remain indwelling greater than 30 days at a time
  • Patient is more than 19 years of age
  • Patient is able to give informed consent
  • Patient is able to attend follow-up sessions

You may not qualify if:

  • Patient is less than 19 years of age
  • Patient is pregnant
  • Patient with a known allergy to silicone
  • Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
  • Patient unable to accommodate the catheter
  • Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated. Once the infection has been treated, the patient is eligible for study.
  • Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
  • Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
  • Patient is unable to feel and/or communicate their symptoms
  • Informed consent is unable to be obtained
  • Patient is unable or unwilling to comply with the study follow-up schedule
  • Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
  • Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Stone Centre, VGH/UBC

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Urinary Tract InfectionsInfections

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Dirk Lange, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Arsovska

CONTACT

604-875-4111olga.arsovska@ubc.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients are not told which catheter is inserted at which time point until after they exit the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2016

First Posted

February 1, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 6, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)