E. Coli for Prevention of Catheter UTI in SCI Patients
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|ClinicalTrials.gov Identifier: NCT00458471|
Recruitment Status : Completed
First Posted : April 10, 2007
Last Update Posted : April 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection(UTI)||Device: Insertion of a urinary catheter coated with benign E. coli||Phase 1|
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:
- Evaluate in vivo the safety of urinary catheters that have been pre-inoculated with E. coli 83972.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Official Title:||Evaluate the Safety in Human Subjects of Using Bladder Catheters That Are Pre-Coated With a Biofilm That Contains Living Bacteria Escherichia Coli 83972.|
|Study Start Date :||November 2003|
|Estimated Study Completion Date :||July 2005|
- bladder colonization and rate of urinary tract infection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458471
|United States, Texas|
|Michael E. DeBakey Veterans Affairs Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Barbara W Trautner, MD||Baylor College of Medicine|