Status:
COMPLETED
E. Coli for Prevention of Catheter UTI in SCI Patients
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Urinary Tract Infection(UTI)
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- Patients followed at the Houston VA Medical Center (VAMC) who have sustained spinal cord injury \>18 months earlier, suffer from neurogenic bladder, require an indwelling urinary catheter (either transurethral or suprapubic), and do not have vesicoureteral reflux will be enrolled.
- Women and members of minority groups and their subpopulations will be included in this protocol. We anticipate that the gender and minority representation will match the demographic mix for the SCI Unit of the Houston VAMC. We will initially target inpatients for enrollment simply for the patients' convenience, but we will have a low threshold for enrolling suitable outpatients or patients about to be discharged who live close enough to the VAMC to make home visits feasible.
Exclusion
- Include urolithiasis, indwelling nephrostomy catheter, supravesical urinary diversion, vesicoureteral reflux, current antibiotic therapy, uncontrolled diabetes mellitus, and immunosuppression.
- Women of childbearing age must have a negative pregnancy test before enrolling in the study, and they must utilize effective birth control methods during the study and for 3 months after the study is concluded.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00458471
Start Date
November 1 2003
End Date
July 1 2005
Last Update
April 10 2007
Active Locations (1)
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1
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030