Clinical Trial: Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase IIa Open Label Study to Evaluate the Safety and Antimicrobial Effects of NVC-422 on Bacteriuria in Chronically Catheterized Subjects
Brief 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 Summary:
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.
Sponsor: NovaBay Pharmaceuticals, Inc.
Current Primary Outcome: Evaluate the safety and antimicrobial effect (and its duration) of NVC-422 in urine following bladder instillation in chronically catheterized subjects with bacteriuria [ Time Frame: 7-10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Assess urine concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation [ Time Frame: 1-7 days ]
- Assess plasma concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation [ Time Frame: 1-7 days ]
Original Secondary Outcome: Same as current
Information By: NovaBay Pharmaceuticals, Inc.
Dates:
Date Received: October 28, 2008
Date Started: October 2008
Date Completion:
Last Updated: September 6, 2011
Last Verified: September 2011
