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

Sponsored by:	NovaBay Pharmaceuticals, Inc.
Information provided by:	NovaBay Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00781339

Purpose

The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.

Condition	Intervention	Phase
Asymptomatic Bacteriuria	Drug: sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate	Phase II

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase IIa Open Label Study to Evaluate the Safety and Antimicrobial Effects of NVC-422 on Bacteriuria in Chronically Catheterized Subjects

Further study details as provided by NovaBay Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess urine concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]
Assess plasma concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation [ Time Frame: 1-7 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	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 - once daily for 7 days, held in the bladder for 1 hour

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781339

Locations

United States, Texas
Michael E. Debakey V.A. Medical Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

NovaBay Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Rabih O. Darouiche, M.D.

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	NovaBay Pharmaceuticals, Inc. ( Kenneth D. Krantz, M.D., Ph.D. )
Study ID Numbers:	CL0803, H-23765
Study First Received:	October 28, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00781339 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NovaBay Pharmaceuticals, Inc.:

Bacteriuria
Catheterized
Chronically Catheterized

Study placed in the following topic categories:

Urologic Diseases
Urinary Tract Infections
Bacteriuria

Additional relevant MeSH terms:

Urologic Diseases
Urinary Tract Infections
Infection
Bacteriuria

ClinicalTrials.gov processed this record on May 07, 2009