Catheter-Related InfectionsNCT02899780
Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
A study testing Ultraviolet light emitting optical fiber in people with Catheter-Related Infections, run by Ultraviolet Interventions at 1 site in United States.
Trial summary
This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Ultraviolet light emitting optical fiber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 10 May 2018
- Phase
- Interventional
- 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
- Be at least 18 years of age
- Have the ability to provide informed consent
- Have an implanted dialysis catheter of one of the following models: Medcomp Titan 15.5F x 24 cm or Medcomp Titan 15.5F x 28 cm
- Positive blood culture drawn from the catheter
Who cannot join
- Previous inclusion in study
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.
- Conditions
- Catheter-Related Infections
- Being tested
- Ultraviolet light emitting optical fiber
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraviolet light emitting optical fiberDevice
Also called Lumenati Fiber
A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Ultraviolet arm | Experimental | This arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber. Receives: Device: Ultraviolet light emitting optical fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Measured: Measured immediately after UV treatment
Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Measured: Measured at study end, expected at 1 year.
Secondary outcomes (2)
Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters
Measured: Measured after UV treatment, with results expected in 5 days.
Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.
Measured: Measured at study end, expected at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start11 May 2017
- Primary completion10 May 2018
- Study completion10 May 2018
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ultraviolet Interventions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Responsible party
- Sponsor
- Investigators
- Nabeel Akhter, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899780
- Sponsor's protocol ID
- UVI-Pilot
- Status last verified
- Oct 2018
- First submitted
- 27 Aug 2016
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
- ClinicalTrials.gov ID
- NCT02899780
- Acronym / sponsor ID
- UVI-Pilot
- Conditions
- Catheter-Related Infections
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ultraviolet InterventionsIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland
- Study start
- 11 May 2017 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 14 Sep 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.
This study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultraviolet arm | Experimental | Device: Ultraviolet light emitting optical fiberThis arm will have their dialysis catheters treated with an ultraviolet light emitting optical fiber. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age
- Have the ability to provide informed consent
- Have an implanted dialysis catheter of one of the following models: Medcomp Titan 15.5F x 24 cm or Medcomp Titan 15.5F x 28 cm
- Positive blood culture drawn from the catheter
Key exclusion criteria (2 listed)
- Previous inclusion in study
- Pregnant
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 |
|---|---|---|
| Ultraviolet light emitting optical fiberAlso: Lumenati FiberA ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn. | Device | Ultraviolet arm |
Primary outcome
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Time frame: Measured immediately after UV treatment
Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter
Time frame: Measured at study end, expected at 1 year.
2 secondary outcomes
Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters
Time frame: Measured after UV treatment, with results expected in 5 days.
Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.
Time frame: Measured at study end, expected at 1 year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Nabeel Akhter, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultraviolet light emitting optical fiber in people with Catheter-Related Infections, run by Ultraviolet Interventions at 1 site in United States.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 30 Oct 2018. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter (time frame: Measured immediately after UV treatment). 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 30 Oct 2018.