Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458471
Status:
COMPLETED
Last Update Posted:
2007-04-10
First Post:
2007-04-09
Brief Title:
E Coli for Prevention of Catheter UTI in SCI Patients
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 UTI1 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 andor UTI2 Bacterial interference or using benign bacteria to prevent infection with virulent pathogens3 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 prevent5 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None