Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| H-18309 | Other Grant/Funding Number | Baylor College of Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 prevalent, though not scientifically well supported approach for treating catheter-related lower UTI in patients with spinal cord injury comprises the following:
The results of this research are expected to provide the following major benefits to veterans with spinal cord injury:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy. |
|
| Arm 2 | Active Comparator | Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shortened course of antibiotic therapy | Other | By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect | Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm) |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy | Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf) | Up to 180 days of end of therapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rabih O Darouiche, MD | Michael E. DeBakey VA Medical Center (152) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center (152) | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | New Catheter Arm | Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy. Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse. |
| FG001 | Existing Catheter Arm | Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy. Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | New Catheter Arm | Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy. Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Efficacy Outcome of the Study is Response to Treatment Which Will be Assessed at the End of Therapy. Successful Response to Treatment is Defined as Resolution of Clinical Manifestations of Infection Plus Lack of Growth of the Original Infect | Posted | Number | participants | Patients will be evaluated for signs of continued infection at mid therapy and at the end of antibiotic therapy (day 5 for new catheter arm and day 10 for existing catheter arm) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy. Shortened course of antibiotic therapy: By obtaining a urine culture from a newly inserted catheter we hope to find the true urinary pathogen. In so doing we feel a shorter but pathogen specific course of antibiotic therapy will more successfully prevent urinary tract infection relapse. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| C diff colitis | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rabih Darouiche | Michael E DeBakey VA Medical Center-Baylor College of Medicine | 713-841-3882 | rdarouiche@aol.com |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D001750 | Urinary Bladder, Neurogenic |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Therapy | Other | Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter. |
|
| BG001 | Existing Catheter Arm | Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy. Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Arm 2 |
Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy. Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter. |
|
|
| Secondary | The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy | Relapse of UTI is defined as a recurrence of clinical manifestations of infection plus growth of the original infecting pathogen(s) in urine culture in association with significant pyuria (>10 WBC/phf) | Posted | Number | participants | Up to 180 days of end of therapy |
|
|
|
| 0 |
| 28 |
| 2 |
| 28 |
| EG001 | Arm 2 | Urinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy. Standard Therapy: Patients entered into this arm of the study will receive the standard duration of antibiotic therapy, which will be determined by urine culture results obtained from existing urinary catheter. | 0 | 27 | 2 | 27 |
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |