Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2014
End Date:January 2016

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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.

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.


Inclusion Criteria:

- Subject requiring an indwelling urinary catheter with a history of catheter blockage
and/or encrustation

- Screening within 30 days of randomization

Exclusion Criteria:

- 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
We found this trial at
17
sites
HIgh Point, North Carolina 27262
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HIgh Point, NC
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Albany, NY
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Albuquerque, New Mexico 87109
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Albuquerque, NM
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Burlington, Massachusetts 01805
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Burlington, MA
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Charlotte, North Carolina 28207
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Charlotte, NC
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Downey, CA
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Englewood, New Jersey 07631
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Englewood, NJ
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Greenville, North Carolina 27834
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Greenville, NC
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Long Beach, California 90822
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Long Beach, CA
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Los Angeles, California 90027
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Los Angeles, CA
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Madison, Wisconsin 53715
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Madison, WI
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Mentor, Ohio 44060
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Mentor, OH
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Owings Mills, Maryland 21117
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Owings Mills, MD
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Richmond, Virginia 23249
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Richmond, VA
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Voorhees, New Jersey 08043
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Voorhees, NJ
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West Orange, New Jersey 07052
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from
West Orange, NJ
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