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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00309114 |
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 |
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Urinary Tract Infections |
Procedure: bacterial interference |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Prevention of UTI in Persons With Spinal Cord Injury |
Estimated Enrollment: | 160 |
Study Start Date: | February 2004 |
Estimated Study Completion Date: | January 2008 |
Ages Eligible for Study: | 15 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rabih Darouiche, MD | 713-794-7117 | rabih.darouiche@med.va.gov |
Contact: Colleen Cerra-Stewart, RN |
United States, Georgia | |
Shepherd Center | Recruiting |
Atlanta, Georgia, United States, 30309 | |
Contact: Bruce Green, MD | |
Contact: Amy Clavijo, RN | |
Principal Investigator: Bruce Green, MD | |
United States, Illinois | |
Rehab Institute Chicago | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: David Chen, MD | |
Contact: Diane Hartwig, RN, NP | |
Principal Investigator: David Chen, MD | |
United States, Texas | |
Michael E Debakey VA Medical Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Rabih Darouiche, MD | |
Contact: Colleen Cerra-Stewart, RN | |
Principal Investigator: Rabih Darouiche, M.D. | |
The Institute for Rehabilitation and Research (TIRR) | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: William Donovan, MD | |
Contact: Margaret Rogers, RN | |
Principal Investigator: William Donovan, MD | |
UT Southwestern | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Karen Kowalski, MD | |
Contact: Don Aultman, RN | |
Principal Investigator: Karen Kowalski, MD |
Principal Investigator: | Rabih Darouiche, MD | Baylor College of Medicine |
Study Director: | Richard Hull, PhD | Baylor College of Medicine |
Study ID Numbers: | 5R01HD043943-03 |
Study First Received: | March 30, 2006 |
Last Updated: | April 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00309114 |
Health Authority: | United States: Institutional Review Board |
UTI SCI E coli Prevention |
Spinal Cord Injuries Urologic Diseases Spinal Cord Diseases Urinary Tract Infections |
Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Communicable Diseases Nervous System Diseases Infection |