Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
- Conditions
- Urinary Catheter Blockage and Encrustation
- Interventions
- Registration Number
- NCT02130518
- Lead Sponsor
- NovaBay Pharmaceuticals, Inc.
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
- Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation
- Screening within 30 days of randomization
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Auriclosene Vehicle Solution Auriclosene Vehicle Solution Auriclosene Vehicle Solution, 8 treatments over 4 weeks Auriclosene (AIS) Auriclosene Irrigation Solution, 0.2% Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks
- Primary Outcome Measures
Name Time Method Percent flow rate reduction of study catheters at time of removal Up to 29 Days
- Secondary Outcome Measures
Name Time Method Number of study catheters removed due to clinical catheter blockage Up to 29 days Number of subjects with serious and non-serious adverse events Up to 29 Days
Trial Locations
- Locations (17)
Lahey Hospital and Medical Clinic
🇺🇸Burlington, Massachusetts, United States
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
Urology Center Research Institute
🇺🇸Englewood, New Jersey, United States
The Urological Institute of Northeastern NY
🇺🇸Albany, New York, United States
Urology Group of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Chesapeake Urology Research Associates
🇺🇸Owings Mills, Maryland, United States
Eastern Urological Associates
🇺🇸Greenville, North Carolina, United States
Dean Clinic
🇺🇸Madison, Wisconsin, United States
McKay Urology
🇺🇸Charlotte, 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
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Kessler Institute for Rehabilitation
🇺🇸West Orange, New Jersey, United States
Delaware Valley Urology, LLC
🇺🇸Voorhees, New Jersey, United States