UTI Prophylaxis Using Bacterial Interference Following SCI

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00037921
First received: May 24, 2002
Last updated: May 5, 2010
Last verified: May 2010
  Purpose

Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered benign colonizers and are often left untreated because they may afford some protection against symptomatic infection with more harmful bacteria.

We applied the concept of using benign bacteria to prevent symptomatic infection, so-called bacterial interference, by deliberately colonizing the bladder of patients with SCI with a non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our VA-funded study that compared the rates of symptomatic UTI in patients with SCI while colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study enrollment indicated that deliberate colonization of the bladder of patients with SCI with E. coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However, before this innovative approach of bacterial interference can be successfully applied in the population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of bacterial interference by conducting a prospective, randomized, placebo-controlled clinical trial (objective #1); and (B) enhance the practicality of applying this innovative approach in SCI patients by delineating the bacterial and host factors that can promote successful colonization with E. coli 83972 (objectives #2-3).


Condition Intervention Phase
Urinary Tract Infections
Procedure: Bacterial colonization
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: UTI Prophylaxis Using Bacterial Interference Following SCI

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 40
Study Start Date: January 2001
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: Bacterial colonization

Detailed Description:

A prospective, randomized, placebo-controlled clinical trial will be conducted. Patients who had sustained SCI >18 months earlier, suffer from neurogenic bladder (require intermittent bladder catheterization, an indwelling suprapubic catheter, or an external collection device), and have a history of frequent symptomatic UTI (> 2 episodes during the preceding year) will be eligible for enrollment. Exclusion criteria will include urolithiasis, indwelling nephrostomy catheter, indwelling transurethral foley catheter, supravesical urinary diversion, vesicoureteral reflux, conditions anticipated to require antibiotic therapy for chronic recurrent extraurogenital infections (e.g. infected decubitus ulcers), uncontrolled diabetes mellitus and immunosuppression. Patients considered unreliable to pursue adequate follow-up and those incapable of giving informed consent will also be excluded. Subjects will discontinue all measures to suppress UTI for at least two weeks prior to entry into the study. All patients will have a complete history and physical examination, serum creatinine, plain X-ray of the abdomen (KUB), and urine culture immediately prior to entry into the study. Renal ultrasound and urodynamic evaluation of the urinary tract will also be obtained upon study entry unless they have been performed during the preceding year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SCI UTI

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00037921

Locations
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Rabih Darouiche, MD Michael E. DeBakey VA Medical Center (152)
  More Information

No publications provided

Responsible Party: Darouiche, Rabih - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00037921     History of Changes
Other Study ID Numbers: B2410R
Study First Received: May 24, 2002
Last Updated: May 5, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
SCI
UTI

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on August 19, 2014