NCT02130518

Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: NovaBay Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Catheter Blockage and Encrustation

Interventions

Type	Name	Description
DRUG	Auriclosene Irrigation Solution, 0.2%
DRUG	Auriclosene Vehicle Solution

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2014-05-05
• Last updated: 2015-12-02

Locations

17 sites across 1 country: United States