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

NCT00781339 | Completed Phase 2

• 2 other identifiers: CL0803H-23765
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Asymptomatic Bacteriuria

Keywords

Bacteriuria; Catheterized; Chronically Catheterized

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety and antimicrobial effect (and its duration) of NVC-422 in urine following bladder instillation in chronically catheterized subjects with bacteriuria

  7-10 days

Secondary Outcomes (2)

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

  1-7 days

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

  1-7 days

Study Arms (1)

Active

EXPERIMENTAL

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

Interventions

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

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

Also known as: NVC-422

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaBay Pharmaceuticals, Inc.: lead

Study Sites (1)

Michael E. Debakey V.A. Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bacteriuria

Interventions

NVC-422

Condition Hierarchy (Ancestors)

Urinary Tract Infections; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Rabih O. Darouiche, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 29, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 12, 2011

Record last verified: 2011-09

Locations

US (1)