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

Primary Purpose

Asymptomatic Bacteriuria

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate

About this trial

This is an interventional treatment trial for Asymptomatic Bacteriuria focused on measuring Bacteriuria, Catheterized, Chronically Catheterized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Michael E. Debakey V.A. Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active

Arm Description

Outcomes

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

Secondary Outcome Measures

Assess urine concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation

Assess plasma concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation

Full Information

NCT ID

NCT00781339

First Posted

October 28, 2008

Last Updated

September 6, 2011

Sponsor

NovaBay Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00781339

Brief Title

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

Official Title

A Phase IIa Open Label Study to Evaluate the Safety and Antimicrobial Effects of NVC-422 on Bacteriuria in Chronically Catheterized Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NovaBay Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asymptomatic Bacteriuria

Keywords

Bacteriuria, Catheterized, Chronically Catheterized

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate

Other Intervention Name(s)

NVC-422

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Assess urine concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation

Time Frame

1-7 days

Title

Assess plasma concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation

Time Frame

1-7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rabih O. Darouiche, M.D.

Organizational Affiliation

Baylor College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Michael E. Debakey V.A. Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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

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