NCT00781339

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: NovaBay Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Asymptomatic Bacteriuria

Interventions

Type	Name	Description
DRUG	sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate	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

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-10-29
• Last updated: 2011-09-12

Locations

1 site across 1 country: United States