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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Catheter Blockage and Encrustation
• Intervention / Treatment: Drug: Auriclosene Irrigation Solution, 0.2%; Drug: Auriclosene Vehicle Solution

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Los Amigos Research and Education Institute
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare System
    • Los Angeles, California, United States, 90027
      • Southern California Permanente Medical Group
  • Maryland
    • Owings Mills, Maryland, United States, 21117
      • Chesapeake Urology Research Associates
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Clinic
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Urology Center Research Institute
    • Voorhees, New Jersey, United States, 08043
      • Delaware Valley Urology, LLC
    • West Orange, New Jersey, United States, 07052
      • Kessler Institute for Rehabilitation
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Urology Group of New Mexico
  • New York
    • Albany, New York, United States, 12208
      • The Urological Institute of Northeastern NY
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • McKay Urology
    • Greenville, North Carolina, United States, 27834
      • Eastern Urological Associates
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Great Lakes Medical Research
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire Veterans Affairs Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Dean Clinic
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Auriclosene (AIS); Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks	Drug: Auriclosene Irrigation Solution, 0.2%
PLACEBO_COMPARATOR: Auriclosene Vehicle Solution; Auriclosene Vehicle Solution, 8 treatments over 4 weeks	Drug: Auriclosene Vehicle Solution

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NovaBay Pharmaceuticals, Inc.
• Investigators: Study Director: Kathryn Najafi-Tagol, MD, NovaBay Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): January 1, 2016

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (ESTIMATE): May 5, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CL1401