Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2006-10-31
2008-04-30
Brief Summary
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Detailed Description
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Bacterial interference, or using benign bacteria to prevent infection with virulent pathogens, may offer a solution to the significant problem of recurrent episodes of UTI in persons with SCI. Two trials in persons with SCI of instilling nonpathogenic Escherichia coli (83972) directly into the bladder demonstrated a strong association between colonization with this non-pathogen and decreased frequency of UTI. However, the successful colonization rate of the direct inoculation method was low (51-62%). Since a urinary catheter-associated biofilm, or bacteria plus extracellular matrix, continually seeds the bladder with bacteria, we proposed to use urinary catheters that had been pre-coated with a biofilm of E. coli 83972 as a means to achieve bladder colonization. Our recently completed pilot (B3248P) demonstrated that insertion of urinary catheters pre-coated with E. coli (83972) was an effective and safe method to achieve bladder colonization with this potentially protective strain. The rate of successful colonization with the E. coli-coated catheters was high (10 of 12 subjects, or 83%). However, this pilot was limited to the subpopulation of SCI veterans who utilize chronic indwelling catheters for bladder drainage.
The current proposal expands upon previous work by widening the range of eligible subjects and by simplifying the colonization protocol. Since an intermittent catheterization program (ICP) is a preferred and more common means of managing neurogenic bladders than chronic catheterization, we now plan to test E. coli 83972-coated catheters in persons with SCI who use ICP for bladder drainage. We hypothesize that short-term use (3 days) of E. coli 83972-coated catheters in persons with SCI practicing ICP will lead to successful colonization (persisting 28 days or more) in the majority of subjects. We will also record subjects' rates of symptomatic UTI while colonized with E. coli 83972 and compare these rates to the subjects' baseline rates in the year prior to study entry. Subjects will be able to remove their study catheters at home and to submit urine samples by mail, so the colonization process will simple and convenient. If successful colonization is achieved in this pilot trial, a larger clinical trial will be designed to test the efficacy of these catheters at preventing UTI in persons with SCI.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Arm 1
insertion of E. coli coated catheter
Insertion of urinary catheters coated with E. coli 83972
All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
Interventions
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Insertion of urinary catheters coated with E. coli 83972
All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Barbara Trautner, MD
Role: PRINCIPAL_INVESTIGATOR
Michael E. DeBakey VA Medical Center
Locations
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Michael E DeBakey VA Medical Center
Houston, Texas, United States
Countries
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References
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Burns AC, Petersen NJ, Garza A, Arya M, Patterson JE, Naik AD, Trautner BW. Accuracy of a urinary catheter surveillance protocol. Am J Infect Control. 2012 Feb;40(1):55-8. doi: 10.1016/j.ajic.2011.04.006. Epub 2011 Aug 3.
Other Identifiers
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B4444-P
Identifier Type: -
Identifier Source: org_study_id