NCT02130518

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

17 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

May 1, 2014

Last Update Submit

November 30, 2015

Conditions

Urinary Catheter Blockage and Encrustation

Outcome Measures

Primary Outcomes (1)

  • Percent flow rate reduction of study catheters at time of removal

    Up to 29 Days

Secondary Outcomes (2)

  • 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

Study Arms (2)

Auriclosene (AIS)

EXPERIMENTAL

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

Drug: Auriclosene Irrigation Solution, 0.2%

Auriclosene Vehicle Solution

PLACEBO COMPARATOR

Auriclosene Vehicle Solution, 8 treatments over 4 weeks

Drug: Auriclosene Vehicle Solution

Interventions

Auriclosene Irrigation Solution, 0.2%DRUG
Auriclosene (AIS)
Auriclosene Vehicle SolutionDRUG
Auriclosene Vehicle Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation
  • Screening within 30 days of randomization

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Los Amigos Research and Education Institute

Downey, California, 90242, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Southern California Permanente Medical Group

Los Angeles, California, 90027, United States

Location

Chesapeake Urology Research Associates

Owings Mills, Maryland, 21117, United States

Location

Lahey Hospital and Medical Clinic

Burlington, Massachusetts, 01805, United States

Location

Urology Center Research Institute

Englewood, New Jersey, 07631, United States

Location

Delaware Valley Urology, LLC

Voorhees Township, New Jersey, 08043, United States

Location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

Urology Group of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

The Urological Institute of Northeastern NY

Albany, New York, 12208, United States

Location

McKay Urology

Charlotte, North Carolina, 28207, United States

Location

Eastern Urological Associates

Greenville, North Carolina, 27834, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Great Lakes Medical Research

Mentor, Ohio, 44060, United States

Location

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

Dean Clinic

Madison, Wisconsin, 53715, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

  • Kathryn Najafi-Tagol, MD

    NovaBay Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 5, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

US(17)