E. Coli for Prevention of Catheter UTI in SCI Patients
Condition: Urinary Tract Infection(UTI)
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Evaluate urinary catheters that have been pre-inoculated with E. coli 83972 in a prospective
      clinical trial in SCI patients who require indwelling catheters for bladder drainage:

        1. Evaluate in vivo the safety of urinary catheters that have been pre-inoculated with E.
           coli 83972.

        2. Determine whether insertion of such catheters in human subjects can persistently
           colonize the neurogenic bladder with E. coli 83972. We will define persistent
           colonization as the presence of E. coli 83972 in the urine for 28 days or longer, as
           persons with indwelling catheters typically receive a new catheter every 28 days.

        3. Evaluate the biofilm present on these urinary catheters after 28 days in the bladder by
           using both sonication cultures and confocal microscopy.

      All patients will have a complete history and physical examination, serum creatinine, plain
      X-ray of the abdomen, 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.
    

Intervention name(s): Insertion of a urinary catheter coated with benign E. coli
Intervention type(s): Device
Allocation: Non-Randomized
Primary purpose: Prevention
Keywords: Urinary Catheter; Spinal Cord Injury; Escherichia Coli; Urinary Tract Infection