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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00554996
First Posted: November 7, 2007
Last Update Posted: October 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bacterial Interference for Prevention of Catheter-Associated UTI

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Rate of UTI While Colonized With E. Coli 83972. [ Time Frame: 0-266 days of colonization ]
    Rate of UTI during colonization with E. coli 83972.


Enrollment: 10
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
E. coli 83972 coated urinary catheter
E. coli 83972 coated urinary catheter
Device: E. coli 83972 coated urinary catheter
E. coli 83972 coated urinary catheter

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Have pre-existing bladder colonization

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 > 2.0 mg/dL, or current antibiotic therapy
  • Latex allergy
  • Allergic to 2 or more classes of drugs to which the urinary isolate is susceptible
  • Prostate cancer on hormonal therapy with or without any surgery or radiation therapy anticipated within the next 6 months
  • Prisoners
  • Significant known mental illness or emotional disorder related to organic or inorganic causes
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554996


Locations
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Barbara Trautner, MD Michael E. DeBakey VA Medical Center, Houston, TX
  More Information

Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00554996     History of Changes
Other Study ID Numbers: B4623-R
First Submitted: November 5, 2007
First Posted: November 7, 2007
Results First Submitted: July 16, 2015
Results First Posted: September 16, 2015
Last Update Posted: October 16, 2015
Last Verified: September 2015

Keywords provided by VA Office of Research and Development:
urinary tract infection
urinary catheter
Escherichia coli
biofilm

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases