Urinary Catheter Blockage and EncrustationPhase 2NCT02130518
Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
A Phase 2 study testing Auriclosene Irrigation Solution, 0.2% in people with Urinary Catheter Blockage and Encrustation, run by NovaBay Pharmaceuticals, Inc. at 17 sites in United States.
Trial summary
Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Catheter Blockage and Encrustation
- What is being tested?
- Auriclosene Irrigation Solution, 0.2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2014to Jan 2016
- Phase
- Phase 2
- 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
- Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation
- Screening within 30 days of randomization
Who cannot join
- Systemic antibiotic use within 14 days of first treatment
- Investigational drug or device within 30 days if enrollment
- Current infection requiring treatment with systemic antibiotics
- Pregnant or lactating female
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
The Urological Institute of Northeastern NY
Albany, New York, 12208
Urology Group of New Mexico
Albuquerque, New Mexico, 87109
Lahey Hospital and Medical Clinic
Burlington, Massachusetts, 01805
McKay Urology
Charlotte, North Carolina, 28207
Los Amigos Research and Education Institute
Downey, California, 90242
Urology Center Research Institute
Englewood, New Jersey, 07631
Eastern Urological Associates
Greenville, North Carolina, 27834
Peters Medical Research
High Point, North Carolina, 27262
VA Long Beach Healthcare System
Long Beach, California, 90822
Southern California Permanente Medical Group
Los Angeles, California, 90027
Dean Clinic
Madison, Wisconsin, 53715
Great Lakes Medical Research
Mentor, Ohio, 44060
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Chesapeake Urology Research Associates
Owings Mills, Maryland, 21117
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
Delaware Valley Urology, LLC
Voorhees Township, New Jersey, 08043
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency
Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria such as Proteus mirabilis, encrustation of the catheter is likely to occur.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs and better patient quality of life.
Read more
Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including the urease-producing Proteus mirabilis.
Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle solution.
- Being tested
- Auriclosene Irrigation Solution, 0.2%, Auriclosene Vehicle Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auriclosene Irrigation Solution, 0.2%Drug
Auriclosene Vehicle SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Auriclosene (AIS) | Experimental | Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks Receives: Drug: Auriclosene Irrigation Solution, 0.2% |
| Auriclosene Vehicle Solution | Placebo comparator | Auriclosene Vehicle Solution, 8 treatments over 4 weeks Receives: Drug: Auriclosene Vehicle Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent flow rate reduction of study catheters at time of removal
Measured: Up to 29 Days
Secondary outcomes (2)
Number of study catheters removed due to clinical catheter blockage
Measured: Up to 29 days
Number of subjects with serious and non-serious adverse events
Measured: Up to 29 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Catheter Blockage and EncrustationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathryn Najafi-Tagol, MD, Study director, NovaBay Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130518
- Sponsor's protocol ID
- CL1401
- Status last verified
- Nov 2015
- First submitted
- 1 May 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency
- ClinicalTrials.gov ID
- NCT02130518
- Acronym / sponsor ID
- CL1401
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 5 May 2014 (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.
Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria such as Proteus mirabilis, encrustation of the catheter is likely to occur.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs and better patient quality of life.
Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including the urease-producing Proteus mirabilis.
Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle solution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auriclosene (AIS) | Experimental | Drug: Auriclosene Irrigation Solution, 0.2%Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks |
| Auriclosene Vehicle Solution | Placebo comparator | Drug: Auriclosene Vehicle SolutionAuriclosene Vehicle Solution, 8 treatments over 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation
- Screening within 30 days of randomization
Key exclusion criteria (4 listed)
- Systemic antibiotic use within 14 days of first treatment
- Investigational drug or device within 30 days if enrollment
- Current infection requiring treatment with systemic antibiotics
- Pregnant or lactating female
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 |
|---|---|---|
| Auriclosene Irrigation Solution, 0.2% | Drug | Auriclosene (AIS) |
| Auriclosene Vehicle Solution | Drug | Auriclosene Vehicle Solution |
Primary outcome
Percent flow rate reduction of study catheters at time of removal
Time frame: Up to 29 Days
2 secondary outcomes
Number of study catheters removed due to clinical catheter blockage
Time frame: Up to 29 days
Number of subjects with serious and non-serious adverse events
Time frame: Up to 29 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
Kathryn Najafi-Tagol, MD study director
NovaBay Pharmaceuticals, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auriclosene Irrigation Solution, 0.2% in people with Urinary Catheter Blockage and Encrustation, run by NovaBay Pharmaceuticals, Inc. at 17 sites 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Percent flow rate reduction of study catheters at time of removal (time frame: Up to 29 Days). 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 2 Dec 2015.