Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency

• Status: Unknown status
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaBay Pharmaceuticals, Inc.
• Treatments: Pharmaceutical Solutions

Criteria

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