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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
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
...and 7 more locations
Percent flow rate reduction of study catheters at time of removal
Time frame: Up to 29 Days
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
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