Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency

NovaBay Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Urinary Catheter Blockage and Encrustation

Treatments: Drug: Auriclosene Irrigation Solution, 0.2%; Drug: Auriclosene Vehicle Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02130518

CL1401

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Auriclosene (AIS)

Experimental group

Description:

Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks

Treatment:

Drug: Auriclosene Irrigation Solution, 0.2%

Auriclosene Vehicle Solution

Placebo Comparator group

Description:

Auriclosene Vehicle Solution, 8 treatments over 4 weeks

Treatment:

Drug: Auriclosene Vehicle Solution