Urinary Tract InfectionsPhase 2NCT00037921
UTI Prophylaxis Using Bacterial Interference Following SCI
A Phase 2 study testing Bacterial colonization in people with Urinary Tract Infections, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of UTI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Bacterial colonization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Dec 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- SCI UTI
Who cannot join
None listed.
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
Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered benign colonizers and are often left untreated because they may afford some protection against symptomatic infection with more harmful bacteria.
We applied the concept of using benign bacteria to prevent symptomatic infection, so-called bacterial interference, by deliberately colonizing the bladder of patients with SCI with a non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our VA-funded study that compared the rates of symptomatic UTI in patients with SCI while colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study enrollment indicated that deliberate colonization of the bladder of patients with SCI with E. coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However, before this innovative approach of bacterial interference can be successfully applied in the population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of bacterial interference by conducting a prospective, randomized, placebo-controlled clinical trial (objective #1); and (B) enhance the practicality of applying this innovative approach in SCI patients by delineating the bacterial and host factors that can promote successful colonization with E. coli 83972 (objectives #2-3).
Read the detailed description
A prospective, randomized, placebo-controlled clinical trial will be conducted. Patients who had sustained SCI >18 months earlier, suffer from neurogenic bladder (require intermittent bladder catheterization, an indwelling suprapubic catheter, or an external collection device), and have a history of frequent symptomatic UTI (> 2 episodes during the preceding year) will be eligible for enrollment. Exclusion criteria will include urolithiasis, indwelling nephrostomy catheter, indwelling transurethral foley catheter, supravesical urinary diversion, vesicoureteral reflux, conditions anticipated to require antibiotic therapy for chronic recurrent extraurogenital infections (e.g. infected decubitus ulcers), uncontrolled diabetes mellitus and immunosuppression. Patients considered unreliable to pursue adequate follow-up and those incapable of giving informed consent will also be excluded. Subjects will discontinue all measures to suppress UTI for at least two weeks prior to entry into the study. All patients will have a complete history and physical examination, serum creatinine, plain X-ray of the abdomen (KUB), 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Bacterial colonization
- Keywords
- SCI, UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterial colonizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: Bacterial colonization |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2002 (estimated)
- Study startJan 2001
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Single group
- Masking
- Single blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Rabih Darouiche, MD, Principal investigator, Michael E. DeBakey VA Medical Center (152)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037921
- Sponsor's protocol ID
- B2410R
- Status last verified
- May 2010
- First submitted
- 24 May 2002
- Last updated
- 7 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UTI Prophylaxis Using Bacterial Interference Following SCI
- ClinicalTrials.gov ID
- NCT00037921
- Acronym / sponsor ID
- B2410R
- Conditions
- Urinary Tract Infections
- Keywords
- SCI, UTI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 27 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary tract infection (UTI) is the most common infection in patients with SCI and is a major cause of morbidity and mortality in this population. The bladder of patients with SCI, especially those who have indwelling catheters, is often colonized by bacteria that may or may not cause symptoms of UTI. Bacteria that do not cause symptoms are usually considered benign colonizers and are often left untreated because they may afford some protection against symptomatic infection with more harmful bacteria.
We applied the concept of using benign bacteria to prevent symptomatic infection, so-called bacterial interference, by deliberately colonizing the bladder of patients with SCI with a non-pathogenic prototype of Escherichia coli (strain 83972). The preliminary results of our VA-funded study that compared the rates of symptomatic UTI in patients with SCI while colonized with E. coli 83972 vs. historical rates of symptomatic UTI prior to study enrollment indicated that deliberate colonization of the bladder of patients with SCI with E. coli 83972 is safe and very promising as to its ability to prevent symptomatic UTI. However, before this innovative approach of bacterial interference can be successfully applied in the population of patients with SCI, it is essential to: (A) confirm the ultimate efficacy of bacterial interference by conducting a prospective, randomized, placebo-controlled clinical trial (objective #1); and (B) enhance the practicality of applying this innovative approach in SCI patients by delineating the bacterial and host factors that can promote successful colonization with E. coli 83972 (objectives #2-3).
Detailed description
A prospective, randomized, placebo-controlled clinical trial will be conducted. Patients who had sustained SCI >18 months earlier, suffer from neurogenic bladder (require intermittent bladder catheterization, an indwelling suprapubic catheter, or an external collection device), and have a history of frequent symptomatic UTI (> 2 episodes during the preceding year) will be eligible for enrollment. Exclusion criteria will include urolithiasis, indwelling nephrostomy catheter, indwelling transurethral foley catheter, supravesical urinary diversion, vesicoureteral reflux, conditions anticipated to require antibiotic therapy for chronic recurrent extraurogenital infections (e.g. infected decubitus ulcers), uncontrolled diabetes mellitus and immunosuppression. Patients considered unreliable to pursue adequate follow-up and those incapable of giving informed consent will also be excluded. Subjects will discontinue all measures to suppress UTI for at least two weeks prior to entry into the study. All patients will have a complete history and physical examination, serum creatinine, plain X-ray of the abdomen (KUB), 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Bacterial colonization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SCI UTI
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Bacterial colonization | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
Related trials for Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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 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 Bacterial colonization in people with Urinary Tract Infections, 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 0 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 7 May 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 7 May 2010.