Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients

Study Overview
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Brief Summary
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The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.

Detailed Description
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Catheter-associated urinary tract infection (CAUTI) is a major healthcare problem in the U.S., accounting for approximately 40% of all hospital acquired infections. Microorganisms can colonize the catheter extraluminally or intraluminally, and are often protected in a biofilm environment. Nearly all patients catherized for 30 days or longer will develop bacteriuria, or the presence of bacteria in normally sterile urine. Ten to twenty percent of these patients will develop a symptomatic CAUTI. In a further 1-4%, the infection will spread into the kidneys or bloodstream, leading to potentially lethal bacteremia. Currently, there is no bladder irrigation solution that can reduce or eliminate CAUTI. A bladder instillation solution that can keep the bladder and catheter substantially free of bacteria and biofilm is expected to provide a practical and cost-effective means of minimizing CAUTIs. NVC-422 is a topical, non-antibiotic, fast acting, broad spectrum anti-microbial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including Escherichia Coli (E. coli), Enterococcus spp., P. mirabilis and others. In vitro studies with NVC-422 have also shown that it is capable of penetrating a biofilm and effectively killing the contained microbes.

Official Title
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A Phase IIa Open Label Study to Evaluate the Safety and Antimicrobial Effects of NVC-422 on Bacteriuria in Chronically Catheterized Subjects

Conditions
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Asymptomatic Bacteriuria

Intervention / Treatment
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* Drug: sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients or their guardians are willing and able to provide informed consent Age > 18 years Condition requiring chronic transurethral catheterization for at least 1 month prior to enrollment Indwelling transurethral catheter not scheduled for exchange for at least 1 week from first treatment Documented asymptomatic bacteriuria as defined in the protocol Vital signs within the following limits: blood pressure 90 to 160 mm Hg systolic and 50 to100 mm Hg diastolic, pulse rate 45 to 100 bpm, respiratory rate 8 to 24 respirations per minute, oral body temperature 35.5ºC to 38.0ºC Screening must occur within 14 days of enrollment into the study Exclusion Criteria: Unwillingness/inability to fulfill the requirements of the study History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease Systemic antibiotics within 7 days of enrollment Any condition that, in the opinion of the principal investigator, would make the subject unsuitable for the study or place the subject at additional risk. Any investigational drug or investigational device within 30 days of enrollment in the study Women who are pregnant or lactating; or of child-bearing potential unless using highly effective birth control method for 1 month prior to and during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate<br>* 0.1% NVC-422 in saline, up to 100 mL, Study Part 1 - once on Day 1 held in the bladder for 1 hour; Study Part 2 (Part 2a - 0.1% NVC-422, Part 2b - 0.2% NVC-422), once daily for 7 days, held in the bladder for 1 hour<br>* Other names: NVC-422;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and antimicrobial effect (and its duration) of NVC-422 in urine following bladder instillation in chronically catheterized subjects with bacteriuria |  | 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess urine concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation |  | 1-7 days | 
| Assess plasma concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation |  | 1-7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteriuria, Catheterized, Chronically Catheterized