Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency

Status unconfirmed · Phase 2

Conditions studied: Urinary Catheter Blockage and Encrustation

In brief

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.

Key facts

Study ID

NCT02130518

Run by

NovaBay Pharmaceuticals, Inc.

People needed

140

Starts

2014-09-01

Expected to finish

2016-01-01

Last updated by the study team

2015-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation
• Screening within 30 days of randomization

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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