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

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ClinicalTrials.gov Identifier: NCT00554996
Recruitment Status : Completed
First Posted : November 7, 2007
Results First Posted : September 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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

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

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : August 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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
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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
US Department of Veterans Affairs
Investigators
Principal Investigator: Barbara Trautner, MD Michael E. DeBakey VA Medical Center, Houston, TX
More Information
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Publications of Results:

Other Publications:

Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00554996     History of Changes
Other Study ID Numbers: B4623-R
First Posted: November 7, 2007    Key Record Dates
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 ( US Department of Veterans Affairs ):
urinary tract infection
urinary catheter
Escherichia coli
biofilm

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases