Spinal Cord InjuryPhase 2NCT00732238
Multifaceted Treatment of Catheter-related Urinary Tract Infection
A Phase 2 study testing Shortened course of antibiotic therapy and Standard Therapy in people with Spinal Cord Injury and Neurogenic Bladder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Bladder, Urinary Tract Infection
- What is being tested?
- Shortened course of antibiotic therapy and Standard Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with SCI who are hospitalized at the Michael E. Debakey VA Medical Center and suffer from lower UTI associate with an indwelling transurethral or suprapubic bladder catheter will be enrolled in the study
Who cannot join
- Exclusion criteria will include septicemia, chronic antimicrobial therapy and inability, or unwillingness to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
About this study
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.
Read the 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 (i.e. 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.
- Being tested
- Shortened course of antibiotic therapy, Standard Therapy
- Keywords
- Spinal Cord Injury, Urinary Tract Infection, Catheter Dependent
- Medical subject headings
- Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortened course of antibiotic therapyOther
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.
Standard TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Removal of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy. Receives: Other: Shortened course 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. Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Secondary outcomes (1)
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)
Measured: Up to 180 days of end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rabih O Darouiche, MD, Principal investigator, Michael E. DeBakey VA Medical Center (152)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732238
- Sponsor's protocol ID
- B4747-P
- Other IDs
- H-18309
- Status last verified
- Jan 2015
- First submitted
- 6 Aug 2008
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifaceted Treatment of Catheter-related Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT00732238
- Acronym / sponsor ID
- B4747-P
- Keywords
- Spinal Cord Injury, Urinary Tract Infection, Catheter Dependent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Posted 3 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (i.e. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Shortened course of antibiotic therapyRemoval of Bladder Catheter. Urine Culture Post Catheter Removal. Shorter Duration of Antibiotic Therapy. |
| Arm 2 | Active comparator | Other: Standard TherapyUrinary Catheter Is Not Exchanged. Antibiotic Therapy Is Based On Culture Obtained From Existing Catheter. Longer Duration of Antibiotic Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with SCI who are hospitalized at the Michael E. Debakey VA Medical Center and suffer from lower UTI associate with an indwelling transurethral or suprapubic bladder catheter will be enrolled in the study
Key exclusion criteria (1 listed)
- Exclusion criteria will include septicemia, chronic antimicrobial therapy and inability, or unwillingness to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shortened course of antibiotic therapyBy 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. | Other | Arm 1 |
| Standard TherapyPatients 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. | Other | Arm 2 |
Primary outcome
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
Time frame: 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)
1 secondary outcome
The Secondary Efficacy Outcome is Recurrence of UTI up to 180 Days After the End of Therapy
Time frame: Up to 180 days of end of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabih O Darouiche, MD principal investigator
Michael E. DeBakey VA Medical Center (152)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shortened course of antibiotic therapy and Standard Therapy in people with Spinal Cord Injury and Neurogenic Bladder, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015.