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E. Coli for Prevention of Catheter UTI in SCI Patients

NCT00458471 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2007-04-10

No results posted yet for this study

Summary

The overall goal of this project is to develop a new approach for the prevention of urinary tract infection (UTI) in persons who rely on indwelling catheters for bladder drainage. Veterans with spinal cord injury (SCI) frequently require chronic bladder catheterization. Most individuals with SCI have neurogenic bladders, and the resulting urinary stasis and bladder catheterization predispose them to recurrent UTI.1 The presence of a urinary catheter dramatically increases the risk of UTI, not only through contamination of the urinary tract during catheter changes, but also by the presence of a foreign body in the urethra and bladder. Implanted urinary catheters rapidly acquire a complex, three-dimensional biofilm composed of bacteria, their extracellular products, and components deposited from bodily fluids. The pathogenic organisms in a biofilm continually seed the bladder, leading to bacteriuria and/or UTI.2 Bacterial interference, or using benign bacteria to prevent infection with virulent pathogens,3, 4 may offer a solution to the significant problem of recurrent episodes of UTI in persons with indwelling catheters. Since biofilm formation on a wet implanted device such as a urinary catheter is nearly impossible to prevent,5, 6 we propose instead to manipulate the adherent microbial flora. We propose that inserting urinary catheters than have been pre-inoculated with a benign strain of Escherichia coli (83972) will be an efficient means to colonize the neurogenic bladder with this harmless organism. If successful colonization is achieved in this pilot trial, a larger clinical trial will be designed to test the efficacy of this approach to prevent bladder colonization by pathogenic organisms and thus to prevent UTI.

Conditions

  • Urinary Tract Infection(UTI)

Interventions

DEVICE

Insertion of a urinary catheter coated with benign E. coli

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Barbara W Trautner, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Completion
2005-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00458471 on ClinicalTrials.gov