Asymptomatic Bacteriuria Clinical Trial
Official title:
A Phase IIa Open Label Study to Evaluate the Safety and Antimicrobial Effects of NVC-422 on Bacteriuria in Chronically Catheterized Subjects
The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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