Urinary Tract Infection(UTI)Phase 1NCT00458471
E. Coli for Prevention of Catheter UTI in SCI Patients
A Phase 1 study testing Insertion of a urinary catheter coated with benign E. coli in people with Urinary Tract Infection(UTI), run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Urinary Tract Infection(UTI)
- What is being tested?
- Insertion of a urinary catheter coated with benign E. coli
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jul 2005
- Phase
- Phase 1
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients followed at the Houston VA Medical Center (VAMC) who have sustained spinal cord injury >18 months earlier, suffer from neurogenic bladder, require an indwelling urinary catheter (either transurethral or suprapubic), and do not have vesicoureteral reflux will be enrolled.
- Women and members of minority groups and their subpopulations will be included in this protocol. We anticipate that the gender and minority representation will match the demographic mix for the SCI Unit of the Houston VAMC. We will initially target inpatients for enrollment simply for the patients' convenience, but we will have a low threshold for enrolling suitable outpatients or patients about to be discharged who live close enough to the VAMC to make home visits feasible.
Who cannot join
- Include urolithiasis, indwelling nephrostomy catheter, supravesical urinary diversion, vesicoureteral reflux, current antibiotic therapy, uncontrolled diabetes mellitus, and immunosuppression.
- Women of childbearing age must have a negative pregnancy test before enrolling in the study, and they must utilize effective birth control methods during the study and for 3 months after the study is concluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
About this study
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.
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 UTI.1 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 and/or UTI.2 Bacterial interference, or using benign bacteria to prevent infection with virulent pathogens,3, 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 prevent,5, 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.
Read the 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:
- Evaluate in vivo the safety of urinary catheters that have been pre-inoculated with E. coli 83972.
- 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.
- 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.
- Conditions
- Urinary Tract Infection(UTI)
- Being tested
- Insertion of a urinary catheter coated with benign E. coli
- Keywords
- Urinary Catheter, Spinal Cord Injury, Escherichia Coli, Urinary Tract Infection
- Medical subject headings
- Urinary Tract Infections, Spinal Cord Injuries, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion of a urinary catheter coated with benign E. coliDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
bladder colonization and rate of urinary tract infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startNov 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection(UTI)Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Barbara W Trautner, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458471
- Sponsor's protocol ID
- H-11717
- Status last verified
- Apr 2007
- First submitted
- 9 Apr 2007
- Last updated
- 10 Apr 2007
- Results posted
- No
Publications
Stamm WE. Catheter-associated urinary tract infections: epidemiology, pathogenesis, and prevention. Am J Med. 1991 Sep 16;91(3B):65S-71S. doi: 10.1016/0002-9343(91)90345-x.
PubMed 1928194Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. doi: 10.1126/science.284.5418.1318.
PubMed 10334980Sprunt K, Leidy G. The use of bacterial interference to prevent infection. Can J Microbiol. 1988 Mar;34(3):332-8. doi: 10.1139/m88-061.
PubMed 3046725Stover SL, Lloyd LK, Waites KB, Jackson AB. Urinary tract infection in spinal cord injury. Arch Phys Med Rehabil. 1989 Jan;70(1):47-54.
PubMed 2644914Habash M, Reid G. Microbial biofilms: their development and significance for medical device-related infections. J Clin Pharmacol. 1999 Sep;39(9):887-98. doi: 10.1177/00912709922008506.
PubMed 10471979Bastable JR, Peel RN, Birch DM, Richards B. Continuous irrigation of the bladder after prostatectomy: its effect on post-prostatectomy infection. Br J Urol. 1977;49(7):689-93. doi: 10.1111/j.1464-410x.1977.tb04554.x.
PubMed 597710Thompson RL, Haley CE, Searcy MA, Guenthner SM, Kaiser DL, Groschel DH, Gillenwater JY, Wenzel RP. Catheter-associated bacteriuria. Failure to reduce attack rates using periodic instillations of a disinfectant into urinary drainage systems. JAMA. 1984 Feb 10;251(6):747-51. doi: 10.1001/jama.251.6.747.
PubMed 6363727
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00458471
- Acronym / sponsor ID
- H-11717
- Conditions
- Urinary Tract Infection(UTI)
- Keywords
- Urinary Catheter, Spinal Cord Injury, Escherichia Coli, Urinary Tract Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Nov 2003
- Study completion
- Jul 2005
- First posted
- 10 Apr 2007 (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.
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 UTI.1 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 and/or UTI.2 Bacterial interference, or using benign bacteria to prevent infection with virulent pathogens,3, 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 prevent,5, 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:
- Evaluate in vivo the safety of urinary catheters that have been pre-inoculated with E. coli 83972.
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients followed at the Houston VA Medical Center (VAMC) who have sustained spinal cord injury >18 months earlier, suffer from neurogenic bladder, require an indwelling urinary catheter (either transurethral or suprapubic), and do not have vesicoureteral reflux will be enrolled.
- Women and members of minority groups and their subpopulations will be included in this protocol. We anticipate that the gender and minority representation will match the demographic mix for the SCI Unit of the Houston VAMC. We will initially target inpatients for enrollment simply for the patients' convenience, but we will have a low threshold for enrolling suitable outpatients or patients about to be discharged who live close enough to the VAMC to make home visits feasible.
Key exclusion criteria (2 listed)
- Include urolithiasis, indwelling nephrostomy catheter, supravesical urinary diversion, vesicoureteral reflux, current antibiotic therapy, uncontrolled diabetes mellitus, and immunosuppression.
- Women of childbearing age must have a negative pregnancy test before enrolling in the study, and they must utilize effective birth control methods during the study and for 3 months after the study is concluded.
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 |
|---|---|---|
| Insertion of a urinary catheter coated with benign E. coli | Device | – |
Primary outcome
bladder colonization and rate of urinary tract infection
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 10 Apr 2007.
- Results publication: PubMed 1928194Stamm WE. Catheter-associated urinary tract infections: epidemiology, pathogenesis, and prevention. Am J Med. 1991 Sep 16;91(3B):65S-71S. doi: 10.1016/0002-9343(91)90345-x.
- Results publication: PubMed 10334980Costerton JW, Stewart PS, Greenberg EP. Bacterial biofilms: a common cause of persistent infections. Science. 1999 May 21;284(5418):1318-22. doi: 10.1126/science.284.5418.1318.
- Results publication: PubMed 3046725Sprunt K, Leidy G. The use of bacterial interference to prevent infection. Can J Microbiol. 1988 Mar;34(3):332-8. doi: 10.1139/m88-061.
- Results publication: PubMed 2644914Stover SL, Lloyd LK, Waites KB, Jackson AB. Urinary tract infection in spinal cord injury. Arch Phys Med Rehabil. 1989 Jan;70(1):47-54.
- Results publication: PubMed 10471979Habash M, Reid G. Microbial biofilms: their development and significance for medical device-related infections. J Clin Pharmacol. 1999 Sep;39(9):887-98. doi: 10.1177/00912709922008506.
- Results publication: PubMed 597710Bastable JR, Peel RN, Birch DM, Richards B. Continuous irrigation of the bladder after prostatectomy: its effect on post-prostatectomy infection. Br J Urol. 1977;49(7):689-93. doi: 10.1111/j.1464-410x.1977.tb04554.x.
- Results publication: PubMed 6363727Thompson RL, Haley CE, Searcy MA, Guenthner SM, Kaiser DL, Groschel DH, Gillenwater JY, Wenzel RP. Catheter-associated bacteriuria. Failure to reduce attack rates using periodic instillations of a disinfectant into urinary drainage systems. JAMA. 1984 Feb 10;251(6):747-51. doi: 10.1001/jama.251.6.747.
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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.
Barbara W Trautner, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insertion of a urinary catheter coated with benign E. coli in people with Urinary Tract Infection(UTI), run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 2 inclusion and 2 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 10 Apr 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
bladder colonization and rate of urinary tract infection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458471, which also lists 7 linked publications.
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 10 Apr 2007.