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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02130518

Enrollment

140

Registered

2014-05-05

Start date

2014-09-30

Completion date

2016-01-31

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Catheter Blockage and Encrustation

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.

Interventions

DRUGAuriclosene Irrigation Solution, 0.2%

DRUGAuriclosene Vehicle Solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026