Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2014 |
End Date: | January 2016 |
A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency
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.
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.
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
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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