Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
NCT ID: NCT02130518
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2014-09-30
2016-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Auriclosene (AIS)
Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks
Auriclosene Irrigation Solution, 0.2%
Auriclosene Vehicle Solution
Auriclosene Vehicle Solution, 8 treatments over 4 weeks
Auriclosene Vehicle Solution
Interventions
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Auriclosene Irrigation Solution, 0.2%
Auriclosene Vehicle Solution
Eligibility Criteria
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Inclusion Criteria
* Screening within 30 days of randomization
Exclusion Criteria
* Investigational drug or device within 30 days if enrollment
* Current infection requiring treatment with systemic antibiotics
* Pregnant or lactating female
18 Years
ALL
No
Sponsors
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NovaBay Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kathryn Najafi-Tagol, MD
Role: STUDY_DIRECTOR
NovaBay Pharmaceuticals, Inc.
Locations
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Los Amigos Research and Education Institute
Downey, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
Southern California Permanente Medical Group
Los Angeles, California, United States
Chesapeake Urology Research Associates
Owings Mills, Maryland, United States
Lahey Hospital and Medical Clinic
Burlington, Massachusetts, United States
Urology Center Research Institute
Englewood, New Jersey, United States
Delaware Valley Urology, LLC
Voorhees Township, New Jersey, United States
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States
Urology Group of New Mexico
Albuquerque, New Mexico, United States
The Urological Institute of Northeastern NY
Albany, New York, United States
McKay Urology
Charlotte, North Carolina, United States
Eastern Urological Associates
Greenville, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Great Lakes Medical Research
Mentor, Ohio, United States
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CL1401
Identifier Type: -
Identifier Source: org_study_id