Clinical trial NCT02130518: Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency
Official title: A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Urinary Catheter Blockage and Encrustation
Lead sponsor: NovaBay Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Percent flow rate reduction of study catheters at time of removal
timeFrame: Up to 29 Days
Secondary outcomes:
measure: Number of study catheters removed due to clinical catheter blockage
timeFrame: Up to 29 days
measure: Number of subjects with serious and non-serious adverse events
timeFrame: Up to 29 Days
Other outcomes:
Locations:
city: Downey
country: United States
facility: Los Amigos Research and Education Institute
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Owings Mills
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Clinic
state: Massachusetts
city: Englewood
country: United States
facility: Urology Center Research Institute
state: New Jersey
city: Voorhees
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico
state: New Mexico
city: Albany
country: United States
facility: The Urological Institute of Northeastern NY
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Greenville
country: United States
facility: Eastern Urological Associates
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Mentor
country: United States
facility: Great Lakes Medical Research
state: Ohio
city: Richmond
country: United States
facility: McGuire Veterans Affairs Medical Center
state: Virginia
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: NovaBay Pharmaceuticals, Inc.
name: Kathryn Najafi-Tagol, MD
role: STUDY_DIRECTOR
References: