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Prevention of Urinary Tract Infection (UTI) in Persons With Spinal Cord Injury (SCI)

This study has been completed.
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00309114
First received: March 30, 2006
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

Urinary tract infection (UTI) is the most common infection in patients with spinal cord injury (SCI) and is linked to major undesired results or complications including death. The bladder of SCI patients, especially those with indwelling catheters, is usually colonized by bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do not cause symptoms are often called benign colonizers and are often left untreated because they may provide some protection against infection with more harmful bacteria. This idea of using benign bacteria to prevent infections with symptoms is called bacterial interference. A prototype strain, Escherichia coli 83972, was shown to begin and continue for extended periods of time non symptom causing colonization of the human bladder and to hold back symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical centers indicated that bacterial interference might be a useful therapy for reducing the rate or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time, and also the large costs of treating this infection, studying the impact of bladder colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential for improving the quality of life of SCI patients and decreasing the cost of health care. Like with other preventive plans such as vaccination, for instance, it is important to explore the effectiveness of this new preventive approach. The project is a prospective, randomized, double blind, multi-center study that deals with specific pieces of bacterial interference in SCI patients.

HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders reduces the rate of symptom causing UTI.

A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria affects the rate of symptom causing urinary tract infections in a large group of SCI and Spina Bifida patients by conducting a prospective, randomized, placebo-controlled, multi-center clinical trial.


Condition Intervention Phase
Urinary Tract Infections
 Procedure: bacterial interference
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of UTI in Persons With Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Putting E. coli 83972 into the bladder of SCI patients reduces the rate of symptomatic UTI. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Study the affect of bladder colonization with E. coli 83972 on the rate of symptom causing UTI in a large group of SCI and Spina Bifida patients. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 15 years or older
  • Living in institutional or non-institutional settings
  • 6 months post spinal cord injury (SCI) prior to entry or have Spina Bifida
  • Loss of bladder function
  • Loss of normal bladder sensation
  • Selected in-patients involved in the Rehab I program
  • Catheter dependent, having either an indwelling urinary catheter or using an external catheter, intermittent catheterization, or vesical urinary diversion (original bladder, whole or in part, serves as the collection receptacle for urine) for bladder management.
  • Two or more urinary tract infections (UTI) within the 12 months prior to the study.
  • Capable of understanding the purpose of the study and providing informed consent to participate
  • Pursue appropriate follow-up over the course of the study.

Exclusion Criteria:

  • Any bladder stone(s)
  • Kidney stone(s) greater than 1 cm in size
  • Any obstructing kidney stone regardless of size
  • Nephrostomy tube(s)
  • Supravesical diversion (original bladder is no longer part of the collection receptacle for urine)
  • Congenital genitourinary anomaly that predisposes to UTI
  • Conditions anticipated to require recurrent antibiotic therapy for extraurogenital infection (e.g., recurrent pneumonia, decubitus ulcer)
  • Current immunosuppression
  • Vascular prosthesis
  • Congenital or acquired cardiac disease susceptible to vegetative infections
  • Bladder capacity of less than 50 cc
  • Individuals with known significant cognitive impairment resulting from trauma, disease, or congenital conditions
  • Women of childbearing age who engage in unprotected intercourse
  • Women who are currently pregnant will be included in the study
  • Women who become pregnant during the study will be discontinued from participation. Pregnant women who experience UTI or prolonged asymptomatic bacteriuria are at risk of bearing infants with low birth weight.
  • Children
  • Prisoners
  • Men and women with significant known mental illness or emotional disorders related to organic or inorganic causes.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00309114

Locations
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, Illinois
Rehab Institute Chicago
Chicago, Illinois, United States, 60611
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Michael E Debakey VA Medical Center
Houston, Texas, United States, 77030
The Institute for Rehabilitation and Research (TIRR)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Rabih Darouiche, MD Baylor College of Medicine
Study Director: Barbara Trautner, MD, PhD Baylor College of Medicine
  More Information

Publications:

Responsible Party: Joan Werner/ Admin Coordinator/ Sr VP & Dean of Research Office, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00309114     History of Changes
Other Study ID Numbers: 5R01HD043943-03
Study First Received: March 30, 2006
Last Updated: November 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
UTI
SCI
E coli
Prevention

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Tract Infections
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Wounds and Injuries
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013