This trial is active, not recruiting.

Condition urinary catheter blockage and encrustation
Treatments auriclosene irrigation solution, 0.2%, auriclosene vehicle solution
Phase phase 2
Sponsor NovaBay Pharmaceuticals, Inc.
Start date September 2014
End date December 2015
Trial size 140 participants
Trial identifier NCT02130518, CL1401


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks
auriclosene irrigation solution, 0.2%
(Placebo Comparator)
Auriclosene Vehicle Solution, 8 treatments over 4 weeks
auriclosene vehicle solution

Primary Outcomes

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

Secondary Outcomes

Number of study catheters removed due to clinical catheter blockage
time frame: Up to 29 days
Number of subjects with serious and non-serious adverse events
time frame: Up to 29 Days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by NovaBay Pharmaceuticals, Inc..