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Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study

This study is currently recruiting participants.
Verified March 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00554996
First received: November 5, 2007
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

This study is a prospective pilot clinical trial investigating the use of urinary catheters coated with benign E. coli in geriatric subjects.


Condition Intervention Phase
Urinary Tract Infection
 Device: E. coli 83972 coated urinary catheter
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Bacterial Interference for Prevention of Catheter-Associated UTI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Safety--lack of symptoms attributable to study catheter or bladder colonization with E. coli 83972. Rate of UTI while colonized with E. coli 83972. [ Time Frame: during 1-3 months of bladder colonization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of UTI while colonized with E. coli 83972 [ Time Frame: during 1-3 months of bladder colonization ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: August 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Device: E. coli 83972 coated urinary catheter
E. coli 83972 coated urinary catheter

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients followed at the MEDVAMC
  • Require an indwelling bladder catheter (either transurethral or suprapubic)
  • Have a history of at least 1 UTI in the past will be eligible for enrollment

Exclusion Criteria:

  • obstructive urolithiasis
  • percutaneous nephrostomy catheters
  • supravesicular urinary diversion
  • vesicoureteral reflux
  • active malignancy
  • uncontrolled diabetes mellitus
  • AIDS
  • requirement for immunosuppressive medication, expected survival < 6 months, creatinine clearance < 10 ml/min, or current antibiotic therapy
  • subjects who are not capable of giving informed consent will not be included unless the subject's designated decision-maker is readily available
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554996

Contacts
Contact: Barbara Trautner, MD (713) 794-7462 barbara.trautner@va.gov
Contact: Deborah Horwitz, PA-C (713) 794-7052 deborah.horwitz@va.gov

Locations
United States, Texas
Michael E DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Suzette Stine, MBA BS     713-794-8654     suzette.stine@va.gov    
Principal Investigator: Barbara Trautner, MD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Barbara Trautner, MD Michael E DeBakey VA Medical Center
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00554996     History of Changes
Other Study ID Numbers: B4623-R
Study First Received: November 5, 2007
Last Updated: March 19, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
urinary tract infection
urinary catheter
Escherichia coli
biofilm

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013