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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auriclosene (AIS) | Experimental | Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks |
|
| Auriclosene Vehicle Solution | Placebo Comparator | Auriclosene Vehicle Solution, 8 treatments over 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auriclosene Irrigation Solution, 0.2% | Drug |
| ||
| Auriclosene Vehicle Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Percent flow rate reduction of study catheters at time of removal | Up to 29 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Najafi-Tagol, MD | NovaBay Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Amigos Research and Education Institute | Downey | California | 90242 | United States | ||
| VA Long Beach Healthcare System |
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| Drug |
|
| Long Beach |
| California |
| 90822 |
| United States |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | United States |
| Chesapeake Urology Research Associates | Owings Mills | Maryland | 21117 | United States |
| Lahey Hospital and Medical Clinic | Burlington | Massachusetts | 01805 | United States |
| Urology Center Research Institute | Englewood | New Jersey | 07631 | United States |
| Delaware Valley Urology, LLC | Voorhees Township | New Jersey | 08043 | United States |
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States |
| Urology Group of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| The Urological Institute of Northeastern NY | Albany | New York | 12208 | United States |
| McKay Urology | Charlotte | North Carolina | 28207 | United States |
| Eastern Urological Associates | Greenville | North Carolina | 27834 | United States |
| Peters Medical Research | High Point | North Carolina | 27262 | United States |
| Great Lakes Medical Research | Mentor | Ohio | 44060 | United States |
| McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | United States |
| Dean Clinic | Madison | Wisconsin | 53715 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |