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Antimicrobial

Auriclosene (AIS) for Urinary Catheter Blockage and Encrustation

Phase 2
Waitlist Available
Research Sponsored by NovaBay Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 29 days
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 29 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 29 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent flow rate reduction of study catheters at time of removal
Secondary outcome measures
Number of study catheters removed due to clinical catheter blockage
Number of subjects with serious and non-serious adverse events

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Auriclosene (AIS)Experimental Treatment1 Intervention
Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks
Group II: Auriclosene Vehicle SolutionPlacebo Group1 Intervention
Auriclosene Vehicle Solution, 8 treatments over 4 weeks

Find a Location

Who is running the clinical trial?

NovaBay Pharmaceuticals, Inc.Lead Sponsor
9 Previous Clinical Trials
1,386 Total Patients Enrolled
1 Trials studying Urinary Catheter Blockage and Encrustation
67 Patients Enrolled for Urinary Catheter Blockage and Encrustation
Kathryn Najafi-Tagol, MDStudy DirectorNovaBay Pharmaceuticals, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~13 spots leftby Apr 2025