Ignite Creation Date:
2024-05-05 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00732238
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2008-08-06
Brief Title:
Multifaceted Treatment of Catheter-related Urinary Tract Infection
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Multifaceted Treatment of Catheter-related Urinary Tract Infection
Status:
COMPLETED
Status Verified Date:
2015-01
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 specific objective of this clinical trial is to demonstrate that a multifaceted approach for treatment for catheter-related urinary tract infection UTI in patients with spinal cord injury is effective and feasible We plan to test the following hypothesis a multifaceted treatment approach that consists of immediate removal of the indwelling bladder catheter selecting antibiotics based on the finding from a urine culture that is obtained through the newly inserted catheter and a 5-day course of systemic antibiotics will effectively treat catheter-related infection that is limited to the lower urinary tract of patients with spinal cord injury
Detailed Description:
UTI is the most common infection in patients with spinal cord injury who require a catheter to drain urine from their bladder These infections can cause serious medical complications such as bloodstream infection decreased kidney function prolonged hospitalization and add great cost Unfortunately the treatment of catheter-related urinary tract infection has not been standardized in this population in terms of
the need to replace the indwelling catheter
the necessity to provide antibiotic coverage against all organisms grown from urine cultures and
the duration of antibiotic treatment
The prevalent though not scientifically well supported approach for treating catheter-related lower UTI in patients with spinal cord injury comprises the following
Retaining the original bladder catheter in place upon diagnosis of infection because of the theoretical concern that removal of the infected catheter may potentially cause the infecting organism to move from the bladder to the bloodstream bacteremia This theoretical complication however is very unlikely and even if it does occur the bacteria would only remain in the bloodstream for a very short period of time and would not have a significant impact on the patient In contrast we propose that immediate removal of the original indwelling bladder catheter with its film of protected bacteria can enhance resolution of UTI
Providing antibiotic coverage against all organisms which grow from a urine culture that is obtained from the original indwelling bladder catheter Although this source of urine culture is a sensitive method for identifying the organisms that are present in the urine it suffers from poor specificity because it may yield the growth of some organisms that could have colonized the catheter and therefore grown in a culture of urine obtained through that original catheter but did not contribute to UTI This issue is particularly problematic in patients with spinal cord injury because urine cultures in almost half of the cases of UTI in this population yield multiple bacteria Therefore we propose that collection of a urine culture while inserting the new bladder catheter would yield growth of only organisms that truly contribute to UTI and therefore obviate the need to administer unnecessary antibiotics to cover additional organisms that would grow only from urine cultures obtained through the original catheter
Treatment with systemic antibiotics for 10 days There exists however no prospective randomized clinical trials indicating that this duration of antibiotic therapy is optimal in patients with spinal cord injury Since catheter-free able-bodied patients with lower UTI are successfully treated with courses of antibiotics as short as 1-3 days we propose that by removing the focus of infection ie the original catheter a 5-day course of systemic antibiotics would be sufficient for treating catheter-related lower UTI in patients with spinal cord injury
The results of this research are expected to provide the following major benefits to veterans with spinal cord injury
the multifaceted approach will provide highly effective treatment of UTI
the lower number of antibiotics that are administered to cover the organisms grown from urine cultures obtained at the time of inserting the replacement bladder catheter will result in lower cost of treatment and a reduced risk for developing antibiotic resistance
the shorter duration of antibiotic course will decrease the overall cost of treatment reduce hospital stay and shorten rehabilitation down time
the need to replace the indwelling catheter
the necessity to provide antibiotic coverage against all organisms grown from urine cultures and
the duration of antibiotic treatment
The prevalent though not scientifically well supported approach for treating catheter-related lower UTI in patients with spinal cord injury comprises the following
Retaining the original bladder catheter in place upon diagnosis of infection because of the theoretical concern that removal of the infected catheter may potentially cause the infecting organism to move from the bladder to the bloodstream bacteremia This theoretical complication however is very unlikely and even if it does occur the bacteria would only remain in the bloodstream for a very short period of time and would not have a significant impact on the patient In contrast we propose that immediate removal of the original indwelling bladder catheter with its film of protected bacteria can enhance resolution of UTI
Providing antibiotic coverage against all organisms which grow from a urine culture that is obtained from the original indwelling bladder catheter Although this source of urine culture is a sensitive method for identifying the organisms that are present in the urine it suffers from poor specificity because it may yield the growth of some organisms that could have colonized the catheter and therefore grown in a culture of urine obtained through that original catheter but did not contribute to UTI This issue is particularly problematic in patients with spinal cord injury because urine cultures in almost half of the cases of UTI in this population yield multiple bacteria Therefore we propose that collection of a urine culture while inserting the new bladder catheter would yield growth of only organisms that truly contribute to UTI and therefore obviate the need to administer unnecessary antibiotics to cover additional organisms that would grow only from urine cultures obtained through the original catheter
Treatment with systemic antibiotics for 10 days There exists however no prospective randomized clinical trials indicating that this duration of antibiotic therapy is optimal in patients with spinal cord injury Since catheter-free able-bodied patients with lower UTI are successfully treated with courses of antibiotics as short as 1-3 days we propose that by removing the focus of infection ie the original catheter a 5-day course of systemic antibiotics would be sufficient for treating catheter-related lower UTI in patients with spinal cord injury
The results of this research are expected to provide the following major benefits to veterans with spinal cord injury
the multifaceted approach will provide highly effective treatment of UTI
the lower number of antibiotics that are administered to cover the organisms grown from urine cultures obtained at the time of inserting the replacement bladder catheter will result in lower cost of treatment and a reduced risk for developing antibiotic resistance
the shorter duration of antibiotic course will decrease the overall cost of treatment reduce hospital stay and shorten rehabilitation down time
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H-18309 | OTHER_GRANT | Baylor College of Medicine | None |