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

This study has suspended participant recruitment.
(FDA has approved our request to put trial on clinical hold because human subjs "are or would be exposed to an unreasonable & significant risk of illness/injury")
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00554996
First received: November 5, 2007
Last updated: April 18, 2014
Last verified: April 2014
  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:


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 > 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554996

Locations
United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
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: April 18, 2014
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:
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014