Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
This trial is active, not recruiting.
|Condition||urinary catheter blockage and encrustation|
|Treatments||auriclosene irrigation solution, 0.2%, auriclosene vehicle solution|
|Sponsor||NovaBay Pharmaceuticals, Inc.|
|Start date||September 2014|
|End date||December 2015|
|Trial size||140 participants|
|Trial identifier||NCT02130518, CL1401|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Downey, CA||Los Amigos Research and Education Institute||no longer recruiting|
|Long Beach, CA||VA Long Beach Healthcare System||no longer recruiting|
|Los Angeles, CA||Southern California Permanente Medical Group||no longer recruiting|
|Owings Mills, MD||Chesapeake Urology Research Associates||no longer recruiting|
|Burlington, MA||Lahey Hospital and Medical Clinic||no longer recruiting|
|Englewood, NJ||Urology Center Research Institute||no longer recruiting|
|Voorhees, NJ||Delaware Valley Urology, LLC||no longer recruiting|
|West Orange, NJ||Kessler Institute for Rehabilitation||no longer recruiting|
|Albuquerque, NM||Urology Group of New Mexico||no longer recruiting|
|Albany, NY||The Urological Institute of Northeastern NY||no longer recruiting|
|Charlotte, NC||McKay Urology||no longer recruiting|
|Greenville, NC||Eastern Urological Associates||no longer recruiting|
|High Point, NC||Peters Medical Research||no longer recruiting|
|Mentor, OH||Great Lakes Medical Research||no longer recruiting|
|Richmond, VA||McGuire Veterans Affairs Medical Center||no longer recruiting|
|Madison, WI||Dean Clinic||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks
Auriclosene Vehicle Solution, 8 treatments over 4 weeks
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
Male or female participants at least 18 years old.
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
|Official title||A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency|
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