Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients
|Asymptomatic Bacteriuria||Drug: sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IIa Open Label Study to Evaluate the Safety and Antimicrobial Effects of NVC-422 on Bacteriuria in Chronically Catheterized Subjects|
- 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 ]
- 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 ]
|Study Start Date:||October 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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
Other Name: NVC-422
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781339
|United States, Texas|
|Michael E. Debakey V.A. Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rabih O. Darouiche, M.D.||Baylor College of Medicine|