NCT02835456

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

July 6, 2016

Last Update Submit

January 1, 2017

Conditions

Catheter Associated Urinary Tract Infections

Keywords

CAUTIBiofilmUrinary tract infectionsmicropatternCatheter

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 (6)

  • Incidence of bacteremia

    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

  • Surface analysis of the amount of encrustation

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Group A: Sharklet Catheter

ACTIVE COMPARATOR

Patient requiring indwelling urinary catheter will be randomised into Group A or Group B

Device: Sharklet Catheter insertion

Group B: Silicone Foley Catheter

ACTIVE COMPARATOR

Patient requiring indwelling urinary catheter will be randomised into Group A or Group B

Device: Silicone Foley Catheter insertion

Interventions

Sharklet Catheter insertionDEVICE
Group A: Sharklet Catheter
Silicone Foley Catheter insertionDEVICE
Group B: Silicone Foley Catheter

Eligibility Criteria

Age18 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 3 days.
  • Catheters will not remain indwelling greater than 30 days at a time
  • Patient is more than 18 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 18 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.
  • 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)

Jahn Ferenc South Pest Teaching Hospital

Budapest, 1204, Hungary

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Urology

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 18, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

HU(1)