Catheter Associated Urinary Tract InfectionsPhase 1SHARKLETNCT02835456
Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?
A Phase 1 study testing Sharklet Catheter insertion and Silicone Foley Catheter insertion in people with Catheter Associated Urinary Tract Infections, run by Jahn Ferenc South Pest Teaching Hospital at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Associated Urinary Tract Infections
- What is being tested?
- Sharklet Catheter insertion and Silicone Foley Catheter insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHungary
- Study dates
- Aug 2016to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Sharklet Catheter insertion, Silicone Foley Catheter insertion
- Keywords
- CAUTI, Biofilm, Urinary tract infections, micropattern, Catheter
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sharklet Catheter insertionDevice
Silicone Foley Catheter insertionDevice
| Study group | Role | What they receive |
|---|---|---|
| Group A: Sharklet Catheter | Active comparator | Patient requiring indwelling urinary catheter will be randomised into Group A or Group B Receives: 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 Receives: Device: Silicone Foley Catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (6)
Incidence of bacteremia
Incidence of bacteremia following CA-SUTI
Measured: 12 weeks
Incidence of Crustation
Incidence of catheter obstruction/encrustation requiring removal
Measured: 12 weeks
Incidence of Discomfort
Incidence of significant discomfort/pain requiring removal
Measured: 12 weeks
Surface analysis of the type of bacteria found on each catheter
Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of bacterial colonization
Measured: 12 weeks
Surface analysis of the amount of encrustation
Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of encrustation
Measured: 12 weeks
Surface analysis of the biofilm formation
Surface analysis (e.g., Scanning Electron Microscopy) of removed catheters for qualitative assessment of biofilm formation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Associated Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jahn Ferenc South Pest Teaching Hospital
- Sponsor type
- Other government
- Collaborators
- Cook Group Incorporated
- Responsible party
- Principal investigator, Prof. Peter Tenke, Jahn Ferenc South Pest Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835456
- Sponsor's protocol ID
- RCSFC028514
- Acronym
- SHARKLET
- Status last verified
- Jan 2017
- First submitted
- 6 Jul 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Micropattern on Urinary Catheter Surface Reduce Urinary Tract Infections?
- ClinicalTrials.gov ID
- NCT02835456
- Acronym / sponsor ID
- SHARKLET / RCSFC028514
- Keywords
- CAUTI, Biofilm, Urinary tract infections, micropattern, Catheter
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jahn Ferenc South Pest Teaching HospitalOther government
- Collaborators
- Cook Group Incorporated
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Sharklet Catheter | Active comparator | Device: Sharklet Catheter insertionPatient requiring indwelling urinary catheter will be randomised into Group A or Group B |
| Group B: Silicone Foley Catheter | Active comparator | Device: Silicone Foley Catheter insertionPatient requiring indwelling urinary catheter will be randomised into Group A or Group B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sharklet Catheter insertion | Device | Group A: Sharklet Catheter |
| Silicone Foley Catheter insertion | Device | Group B: Silicone Foley Catheter |
Primary outcome
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
Time frame: 12 weeks
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture.
Time frame: 12 weeks
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
6 secondary outcomes
Incidence of bacteremia
Time frame: 12 weeks
Incidence of Crustation
Time frame: 12 weeks
Incidence of Discomfort
Time frame: 12 weeks
Surface analysis of the type of bacteria found on each catheter
Time frame: 12 weeks
Surface analysis of the amount of encrustation
Time frame: 12 weeks
Surface analysis of the biofilm formation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sharklet Catheter insertion and Silicone Foley Catheter insertion in people with Catheter Associated Urinary Tract Infections, run by Jahn Ferenc South Pest Teaching Hospital at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.