Trial | NCT00781339  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    auriclosene ...

  • Study Participants

    20
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.
Study Started
Oct 31
2008
Primary Completion
Mar 31
2010
Study Completion
Mar 31
2010
Last Update
Sep 12
2011
Estimate

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 names: NVC-422

Active Experimental

Criteria 

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
No Results Posted