Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency

Conditions
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Urinary Catheter Blockage and Encrustation

Intervention / Treatment
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* Drug: Auriclosene Irrigation Solution, 0.2%
* Drug: Auriclosene Vehicle Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auriclosene (AIS)<br>Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks | Drug: Auriclosene Irrigation Solution, 0.2%<br> <br> |
| Placebo Comparator: Auriclosene Vehicle Solution<br>Auriclosene Vehicle Solution, 8 treatments over 4 weeks | Drug: Auriclosene Vehicle Solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent flow rate reduction of study catheters at time of removal |  | Up to 29 Days | 

Secondary Outcome Measures

| Outcome Measure | 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 |