Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)

NCT00482547 | Terminated Phase 4 Results DMC

• 1 other identifier: BMD-6003
• Study Type: interventional
• Target: 1,188
• Locations: 1 country
• Sites: 1

Brief Summary

Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter.

Conditions

Catheterization

Keywords

urinary tract infection; urinary catheter

Outcome Measures

Primary Outcomes (1)

• Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours

  Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.

  >=48 hours to 10 days

Secondary Outcomes (5)

• Percentage of Participants With a bUTI After Catheterization for >= 48 Hours

  >=48 hours to 10 days

• Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours

  >= 48 hours to 10 days

• Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours

  >= 24 hours to 10 days

• Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours

  >= 24 hours to 10 days

• Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL

  10 days

Other Outcomes (2)

• Number of Subjects With a bUTI Catheterized for >=48 Hours.

  From time of catheterization until 10 days post catheterization or 48 hours after catheter removal.

• Number of Subjects With a sUTI Catheterized for >=48 Hours.

  From time of catheterization until 10 days or 48 hours after catheter was removed

Study Arms (2)

Silver-coated catheter

EXPERIMENTAL

Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System

Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System

Silicone-coated catheter

PLACEBO COMPARATOR

Bard silicone elastomer coated latex catheter system

Device: Bard silicone elastomer coated latex catheter system

Interventions

Hydrogel Silver Salts Coated Latex Urinary Catheter System DEVICE

Silver-coated catheter

Also known as: AgSC arm

Silver-coated catheter

Bard silicone elastomer coated latex catheter system DEVICE

Silicone-coated catheter

Also known as: SiCS arm

Silicone-coated catheter

Eligibility Criteria

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

You may qualify if:

• male or female at least 18 years of age
• life expectancy of 3 months or more
• expected to require a urinary catheter for at least 48 hours

You may not qualify if:

• recent urinary tract surgery or instrumentation
• presence of a urinary tract device
• concurrent genitourinary tract infection
• recent indwelling urinary catheter
• requires use of a non-study urinary catheter

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Sample size calculations required 1244 Efficacy Evaluable 48 subjects, only 854 Efficacy Evaluable 48 subjects were enrolled, which does not allow for a fully powered study and there is the threat of a type II error (false negative result).

Results Point of Contact

• Title: Vanessa Dell Clinical Research Scientist
• Organization: C. R. Bard

vanessa.dell@crbard.com

908-277-8094

Study Officials

• Mark Rupp, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 28, 2017
• Results First Posted: January 21, 2010

Record last verified: 2017-01

Locations

US (1)