Urinary Tract InfectionPhase 1NCT00554996
Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study
A Phase 1 study testing E. coli 83972 coated urinary catheter in people with Urinary Tract Infection, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This study is a prospective pilot clinical trial investigating the use of urinary catheters coated with benign E. coli in geriatric subjects. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- E. coli 83972 coated urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2014
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients followed at the MEDVAMC
- Require an indwelling bladder catheter (either transurethral or suprapubic)
- Have a history of at least 1 UTI in the past will be eligible for enrollment
- Have pre-existing bladder colonization
Who cannot join
- obstructive urolithiasis
- percutaneous nephrostomy catheters
- supravesicular urinary diversion
- vesicoureteral reflux
- active malignancy
- uncontrolled diabetes mellitus
Show all 14Show fewer
- AIDS
- requirement for immunosuppressive medication, expected survival < 6 months, creatinine clearance > 2.0 mg/dL, or current antibiotic therapy
- Latex allergy
- Allergic to 2 or more classes of drugs to which the urinary isolate is susceptible
- Prostate cancer on hormonal therapy with or without any surgery or radiation therapy anticipated within the next 6 months
- Prisoners
- Significant known mental illness or emotional disorder related to organic or inorganic causes
- subjects who are not capable of giving informed consent will not be included unless the subject's designated decision-maker is readily available
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Official title: Bacterial Interference for Prevention of Catheter-Associated UTI
This study is a prospective pilot clinical trial investigating the use of urinary catheters coated with benign E. coli in geriatric subjects.
Read the detailed description
- Preparation of study catheters: Urinary catheters will be incubated in broth with E. coli 83972 for 48 hours prior to insertion into patients. Samples of broth will be removed after 24 hours and 48 hours of incubation to test for purity of the E. coli 83972. Study catheters will be inserted after 48 hours of incubation, unless contamination was seen on the 24-hour plates. The 48-hour plates will be read at 72 hours, and any contamination would prompt removal of the study catheter. For subjects who require antibiotics to clear their bladders prior to catheter insertion, we will use a derivative strain of E. coli 83972 with the appropriate antibiotic resistance.
- Screening procedures: Eligible subjects will be identified by chart review and by discussion with health care providers. Research personnel will also periodically assess the inpatient geriatric beds and review upcoming appointments in the geriatric and urology clinics at the MEDVAMC. Potential outpatient subjects may be contacted by telephone before their clinic appointment to advise them of the study. Those wishing to participate will meet with study personnel in person when they come for their clinic appointment. At the time of enrollment, the principal investigator or the research coordinator will explain the study protocol in detail, and subjects will be given a chance to ask questions. Informed consent will be obtained from interested persons at that time. Any necessary screening procedures (history and physical examination, renal ultrasound, serum creatinine, baseline urine culture) will be performed after obtaining informed consent. Subjects who have not had a renal ultrasound within the past 12 months, or a serum creatinine measured within the past 6 months, will undergo these procedures. Also, study personnel will collect urine for culture to determine what organisms are present in the subject's bladder at baseline. The subject may receive 7-10 days of appropriate antibiotics to clear their bladders before insertion of study catheters, depending on the pre-existing bladder flora.
- Insertion of study catheters: Subjects requiring fluoroquinolone antibiotics to clear their bladders will receive a study catheter 4-5 days after completing treatment. Subjects requiring any other class of antibiotics will receive a study catheter 2-3 days after completing antibiotic treatment. The study catheter will be inserted in by research personnel or by the unit nurse. Insertion will be performed using sterile technique. Urine will be collected through the newly inserted study catheters and cultured by study personnel.
- Urine sample collection: Urine samples will be collected through the study catheter on days 1, 3, 7, 14, 21, and 28 after catheter insertion. Urine will be mailed to the PI's laboratory at the MEDVAMC in biological sample collection containers via overnight mail for outpatients, or the samples can be collected directly from inpatients.
- Study catheter removal: A day 28 urine sample will be collected through the study catheter immediately prior to removal. Study catheters will be removed by study personnel at the MEDVAMC. Subjects who still have E. coli 83972 on the day of catheter removal will be given the option of taking antibiotics to eradicate the E. coli 83972 from the bladder or to remain colonized and in the follow-up phase of the study.
- Specimen mailing procedure: We have utilized these specimen mailing supplies before. The study organism, E. coli 83972, has 83% survival after 72 hours in the specimen mailer tubes, when mailed from other locations in Texas and Louisiana. Both the study organism and other uropathogens have likewise been recovered from urinary catheters removed 72 hours previously and sent to us in specimen mailing tubes.
- Microbiologic studies: Semi-quantitative cultures will be performed on each urine sample to determine whether E. coli 83972 is present and the relative concentration of each other species in the urine. The presence in the urine of bacteria other than E. coli will be examined using standard bacteriological methods only. E. coli strains will be assessed using standard microbiological techniques as well as molecular techniques in the research laboratory. Urine will be spread on MacConkey lactose agar plates and incubated to allow bacterial growth. Representative E. coli colonies will be subjected to restriction fragment length polymorphism (RFLP) analysis using pulse field gel electrophoresis (PFGE) to definitively identify E. coli 83972. The removed urinary catheters will be sonicated to extract surface-associated organisms. An aliquot of each sonicate will be plated for identification of organisms.
- Defining outcomes: We will assess the safety and colonization success. For the purposes of this study, we will define successful bladder colonization as persistence of E. coli 83972 in the urine for > 28 days after insertion of the catheter. Shorter duration of colonization will be defined as failure to colonize the bladder. We will also compare the incidence of symptomatic UTI while colonized with E. coli 83972 to the incidence of symptomatic UTI experienced by the subjects in the year prior to study entry.
- Safety assessment: The principal investigator will contact subjects daily for the first 3 days while they are wearing the study catheters, weekly for the remainder of the first 28 days after insertion of the study catheter, and monthly thereafter as long as they remain colonized with E. coli 83972. Subjects will be instructed to contact study personnel for signs or symptoms of UTI, catheter malfunction, or need for antibiotics.
- UTI in elderly subjects can present with constitutional symptoms rather than those localized to the urinary tract, and the fever response can be blunted in the elderly. Symptomatic UTI will be defined as the presence of significant bacteriuria (>102 cfu/ml), pyuria (>10 WBC/hpf) plus > 1 of the following signs and symptoms: fever (> 100.0 F), suprapubic or flank discomfort, bladder spasm, malaise, altered functional status, or altered mental status, provided that no other etiologies for these clinical manifestations can be identified. Subjects' baseline incidence of UTI in the year prior to enrollment will be determined by chart review. Any documented treatment for UTI will be regarded as a symptomatic UTI. We will also inquire whether patients were treated for UTI at an outside facility. Subjects who develop symptomatic UTI will be treated with antibiotics guided by susceptibility patterns for the organism(s) grown from urine cultures.
- Duration of participation: If a subject remains colonized with E. coli 83972 on day 28 after removal of the study catheter, and if the subject declines antibiotics to eradicate the study organism, we will continue to collect monthly urine specimens until the organism is lost from the bladder or until completion of 12 months, whichever comes first. Thus, an individual subject's participation in the study will be limited to 12 months or less.
- Conditions
- Urinary Tract Infection
- Being tested
- E. coli 83972 coated urinary catheter
- Keywords
- urinary tract infection, urinary catheter, Escherichia coli, biofilm
- Medical subject headings
- Urinary Tract Infections, Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli 83972 coated urinary catheterDevice
- coli 83972 coated urinary catheter
| Study group | Role | What they receive |
|---|---|---|
| E. coli 83972 coated urinary catheter | Other | E. coli 83972 coated urinary catheter Receives: Device: E. coli 83972 coated urinary catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of UTI While Colonized With E. Coli 83972.
Rate of UTI during colonization with E. coli 83972.
Measured: 0-266 days of colonization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
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.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Barbara Trautner, MD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554996
- Sponsor's protocol ID
- B4623-R
- Status last verified
- Sep 2015
- First submitted
- 5 Nov 2007
- Last updated
- 16 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Trautner BW, Cevallos ME, Li H, Riosa S, Hull RA, Hull SI, Tweardy DJ, Darouiche RO. Increased expression of type-1 fimbriae by nonpathogenic Escherichia coli 83972 results in an increased capacity for catheter adherence and bacterial interference. J Infect Dis. 2008 Sep 15;198(6):899-906. doi: 10.1086/591093.
PubMed 18643750Buscher A, Li L, Han XY, Trautner BW. Aortic valve endocarditis possibly caused by a Haematobacter-like species. J Clin Microbiol. 2010 Oct;48(10):3791-3. doi: 10.1128/JCM.00238-10. Epub 2010 Jul 7.
PubMed 20610676Desai DG, Liao KS, Cevallos ME, Trautner BW. Silver or nitrofurazone impregnation of urinary catheters has a minimal effect on uropathogen adherence. J Urol. 2010 Dec;184(6):2565-71. doi: 10.1016/j.juro.2010.07.036.
PubMed 21030042Qin G, Santos C, Zhang W, Li Y, Kumar A, Erasquin UJ, Liu K, Muradov P, Trautner BW, Cai C. Biofunctionalization on alkylated silicon substrate surfaces via "click" chemistry. J Am Chem Soc. 2010 Nov 24;132(46):16432-41. doi: 10.1021/ja1025497. Epub 2010 Oct 29.
PubMed 21033708Nelsen A, Trautner BW, Petersen NJ, Gupta S, Rodriguez-Barradas M, Giordano TP, Naik AD. Development and validation of a measure for intention to adhere to HIV treatment. AIDS Patient Care STDS. 2012 Jun;26(6):329-34. doi: 10.1089/apc.2011.0318.
PubMed 22680281Trautner BW, Gupta K. The advantages of second best: comment on "Lactobacilli vs antibiotics to prevent urinary tract infections". Arch Intern Med. 2012 May 14;172(9):712-4. doi: 10.1001/archinternmed.2012.1213. No abstract available.
PubMed 22782200Roig IL, Darouiche RO, Musher DM, Trautner BW. Device-related infective endocarditis, with special consideration of implanted intravascular and cardiac devices in a predominantly male population. Scand J Infect Dis. 2012 Oct;44(10):753-60. doi: 10.3109/00365548.2012.678882. Epub 2012 Jun 10.
PubMed 22681242Gupta K, Trautner B. In the clinic. Urinary tract infection. Ann Intern Med. 2012 Mar 6;156(5):ITC3-1-ITC3-15; quiz ITC3-16. doi: 10.7326/0003-4819-156-5-201203060-01003. No abstract available.
PubMed 22393148Trautner BW, Lopez AI, Kumar A, Siddiq DM, Liao KS, Li Y, Tweardy DJ, Cai C. Nanoscale surface modification favors benign biofilm formation and impedes adherence by pathogens. Nanomedicine. 2012 Apr;8(3):261-70. doi: 10.1016/j.nano.2011.11.014. Epub 2011 Dec 23.
PubMed 22197726Trautner BW, Hull RA, Thornby JI, Darouiche RO. Coating urinary catheters with an avirulent strain of Escherichia coli as a means to establish asymptomatic colonization. Infect Control Hosp Epidemiol. 2007 Jan;28(1):92-4. doi: 10.1086/510872. Epub 2006 Dec 29.
PubMed 17230395Trautner BW, Hull RA, Darouiche RO. Escherichia coli 83972 inhibits catheter adherence by a broad spectrum of uropathogens. Urology. 2003 May;61(5):1059-62. doi: 10.1016/s0090-4295(02)02555-4.
PubMed 12736047Nelsen A, Gupta S, Trautner BW, Petersen NJ, Garza A, Giordano TP, Naik AD, Rodriguez-Barradas MC. Intention to adhere to HIV treatment: a patient-centred predictor of antiretroviral adherence. HIV Med. 2013 Sep;14(8):472-80. doi: 10.1111/hiv.12032. Epub 2013 Apr 3.
PubMed 23551395Marschall J, Carpenter CR, Fowler S, Trautner BW; CDC Prevention Epicenters Program. Antibiotic prophylaxis for urinary tract infections after removal of urinary catheter: meta-analysis. BMJ. 2013 Jun 11;346:f3147. doi: 10.1136/bmj.f3147.
PubMed 23757735Trautner BW, Petersen NJ, Hysong SJ, Horwitz D, Kelly PA, Naik AD. Overtreatment of asymptomatic bacteriuria: identifying provider barriers to evidence-based care. Am J Infect Control. 2014 Jun;42(6):653-8. doi: 10.1016/j.ajic.2014.02.003. Epub 2014 Apr 6.
PubMed 24713596Horwitz D, McCue T, Mapes AC, Ajami NJ, Petrosino JF, Ramig RF, Trautner BW. Decreased microbiota diversity associated with urinary tract infection in a trial of bacterial interference. J Infect. 2015 Sep;71(3):358-367. doi: 10.1016/j.jinf.2015.05.014. Epub 2015 Jun 3.
PubMed 26048203
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Interference for Prevention of Catheter-Associated UTI
- ClinicalTrials.gov ID
- NCT00554996
- Acronym / sponsor ID
- B4623-R
- Conditions
- Urinary Tract Infection
- Keywords
- urinary tract infection, urinary catheter, Escherichia coli, biofilm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Nov 2007 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective pilot clinical trial investigating the use of urinary catheters coated with benign E. coli in geriatric subjects.
Detailed description
- Preparation of study catheters: Urinary catheters will be incubated in broth with E. coli 83972 for 48 hours prior to insertion into patients. Samples of broth will be removed after 24 hours and 48 hours of incubation to test for purity of the E. coli 83972. Study catheters will be inserted after 48 hours of incubation, unless contamination was seen on the 24-hour plates. The 48-hour plates will be read at 72 hours, and any contamination would prompt removal of the study catheter. For subjects who require antibiotics to clear their bladders prior to catheter insertion, we will use a derivative strain of E. coli 83972 with the appropriate antibiotic resistance.
- Screening procedures: Eligible subjects will be identified by chart review and by discussion with health care providers. Research personnel will also periodically assess the inpatient geriatric beds and review upcoming appointments in the geriatric and urology clinics at the MEDVAMC. Potential outpatient subjects may be contacted by telephone before their clinic appointment to advise them of the study. Those wishing to participate will meet with study personnel in person when they come for their clinic appointment. At the time of enrollment, the principal investigator or the research coordinator will explain the study protocol in detail, and subjects will be given a chance to ask questions. Informed consent will be obtained from interested persons at that time. Any necessary screening procedures (history and physical examination, renal ultrasound, serum creatinine, baseline urine culture) will be performed after obtaining informed consent. Subjects who have not had a renal ultrasound within the past 12 months, or a serum creatinine measured within the past 6 months, will undergo these procedures. Also, study personnel will collect urine for culture to determine what organisms are present in the subject's bladder at baseline. The subject may receive 7-10 days of appropriate antibiotics to clear their bladders before insertion of study catheters, depending on the pre-existing bladder flora.
- Insertion of study catheters: Subjects requiring fluoroquinolone antibiotics to clear their bladders will receive a study catheter 4-5 days after completing treatment. Subjects requiring any other class of antibiotics will receive a study catheter 2-3 days after completing antibiotic treatment. The study catheter will be inserted in by research personnel or by the unit nurse. Insertion will be performed using sterile technique. Urine will be collected through the newly inserted study catheters and cultured by study personnel.
- Urine sample collection: Urine samples will be collected through the study catheter on days 1, 3, 7, 14, 21, and 28 after catheter insertion. Urine will be mailed to the PI's laboratory at the MEDVAMC in biological sample collection containers via overnight mail for outpatients, or the samples can be collected directly from inpatients.
- Study catheter removal: A day 28 urine sample will be collected through the study catheter immediately prior to removal. Study catheters will be removed by study personnel at the MEDVAMC. Subjects who still have E. coli 83972 on the day of catheter removal will be given the option of taking antibiotics to eradicate the E. coli 83972 from the bladder or to remain colonized and in the follow-up phase of the study.
- Specimen mailing procedure: We have utilized these specimen mailing supplies before. The study organism, E. coli 83972, has 83% survival after 72 hours in the specimen mailer tubes, when mailed from other locations in Texas and Louisiana. Both the study organism and other uropathogens have likewise been recovered from urinary catheters removed 72 hours previously and sent to us in specimen mailing tubes.
- Microbiologic studies: Semi-quantitative cultures will be performed on each urine sample to determine whether E. coli 83972 is present and the relative concentration of each other species in the urine. The presence in the urine of bacteria other than E. coli will be examined using standard bacteriological methods only. E. coli strains will be assessed using standard microbiological techniques as well as molecular techniques in the research laboratory. Urine will be spread on MacConkey lactose agar plates and incubated to allow bacterial growth. Representative E. coli colonies will be subjected to restriction fragment length polymorphism (RFLP) analysis using pulse field gel electrophoresis (PFGE) to definitively identify E. coli 83972. The removed urinary catheters will be sonicated to extract surface-associated organisms. An aliquot of each sonicate will be plated for identification of organisms.
- Defining outcomes: We will assess the safety and colonization success. For the purposes of this study, we will define successful bladder colonization as persistence of E. coli 83972 in the urine for > 28 days after insertion of the catheter. Shorter duration of colonization will be defined as failure to colonize the bladder. We will also compare the incidence of symptomatic UTI while colonized with E. coli 83972 to the incidence of symptomatic UTI experienced by the subjects in the year prior to study entry.
- Safety assessment: The principal investigator will contact subjects daily for the first 3 days while they are wearing the study catheters, weekly for the remainder of the first 28 days after insertion of the study catheter, and monthly thereafter as long as they remain colonized with E. coli 83972. Subjects will be instructed to contact study personnel for signs or symptoms of UTI, catheter malfunction, or need for antibiotics.
- UTI in elderly subjects can present with constitutional symptoms rather than those localized to the urinary tract, and the fever response can be blunted in the elderly. Symptomatic UTI will be defined as the presence of significant bacteriuria (>102 cfu/ml), pyuria (>10 WBC/hpf) plus > 1 of the following signs and symptoms: fever (> 100.0 F), suprapubic or flank discomfort, bladder spasm, malaise, altered functional status, or altered mental status, provided that no other etiologies for these clinical manifestations can be identified. Subjects' baseline incidence of UTI in the year prior to enrollment will be determined by chart review. Any documented treatment for UTI will be regarded as a symptomatic UTI. We will also inquire whether patients were treated for UTI at an outside facility. Subjects who develop symptomatic UTI will be treated with antibiotics guided by susceptibility patterns for the organism(s) grown from urine cultures.
- Duration of participation: If a subject remains colonized with E. coli 83972 on day 28 after removal of the study catheter, and if the subject declines antibiotics to eradicate the study organism, we will continue to collect monthly urine specimens until the organism is lost from the bladder or until completion of 12 months, whichever comes first. Thus, an individual subject's participation in the study will be limited to 12 months or less.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E. coli 83972 coated urinary catheter | Other | Device: E. coli 83972 coated urinary catheterE. coli 83972 coated urinary catheter |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients followed at the MEDVAMC
- Require an indwelling bladder catheter (either transurethral or suprapubic)
- Have a history of at least 1 UTI in the past will be eligible for enrollment
- Have pre-existing bladder colonization
Key exclusion criteria (14 listed)
- obstructive urolithiasis
- percutaneous nephrostomy catheters
- supravesicular urinary diversion
- vesicoureteral reflux
- active malignancy
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 |
|---|---|---|
| E. coli 83972 coated urinary catheterE. coli 83972 coated urinary catheter | Device | E. coli 83972 coated urinary catheter |
Primary outcome
Rate of UTI While Colonized With E. Coli 83972.
Time frame: 0-266 days of colonization
Rate of UTI during colonization with E. coli 83972.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18643750Trautner BW, Cevallos ME, Li H, Riosa S, Hull RA, Hull SI, Tweardy DJ, Darouiche RO. Increased expression of type-1 fimbriae by nonpathogenic Escherichia coli 83972 results in an increased capacity for catheter adherence and bacterial interference. J Infect Dis. 2008 Sep 15;198(6):899-906. doi: 10.1086/591093.
- Background: PubMed 20610676Buscher A, Li L, Han XY, Trautner BW. Aortic valve endocarditis possibly caused by a Haematobacter-like species. J Clin Microbiol. 2010 Oct;48(10):3791-3. doi: 10.1128/JCM.00238-10. Epub 2010 Jul 7.
- Background: PubMed 21030042Desai DG, Liao KS, Cevallos ME, Trautner BW. Silver or nitrofurazone impregnation of urinary catheters has a minimal effect on uropathogen adherence. J Urol. 2010 Dec;184(6):2565-71. doi: 10.1016/j.juro.2010.07.036.
- Background: PubMed 21033708Qin G, Santos C, Zhang W, Li Y, Kumar A, Erasquin UJ, Liu K, Muradov P, Trautner BW, Cai C. Biofunctionalization on alkylated silicon substrate surfaces via "click" chemistry. J Am Chem Soc. 2010 Nov 24;132(46):16432-41. doi: 10.1021/ja1025497. Epub 2010 Oct 29.
- Background: PubMed 22680281Nelsen A, Trautner BW, Petersen NJ, Gupta S, Rodriguez-Barradas M, Giordano TP, Naik AD. Development and validation of a measure for intention to adhere to HIV treatment. AIDS Patient Care STDS. 2012 Jun;26(6):329-34. doi: 10.1089/apc.2011.0318.
- Background: PubMed 22782200Trautner BW, Gupta K. The advantages of second best: comment on "Lactobacilli vs antibiotics to prevent urinary tract infections". Arch Intern Med. 2012 May 14;172(9):712-4. doi: 10.1001/archinternmed.2012.1213. No abstract available.
- Background: PubMed 22681242Roig IL, Darouiche RO, Musher DM, Trautner BW. Device-related infective endocarditis, with special consideration of implanted intravascular and cardiac devices in a predominantly male population. Scand J Infect Dis. 2012 Oct;44(10):753-60. doi: 10.3109/00365548.2012.678882. Epub 2012 Jun 10.
- Background: PubMed 22393148Gupta K, Trautner B. In the clinic. Urinary tract infection. Ann Intern Med. 2012 Mar 6;156(5):ITC3-1-ITC3-15; quiz ITC3-16. doi: 10.7326/0003-4819-156-5-201203060-01003. No abstract available.
- Background: PubMed 22197726Trautner BW, Lopez AI, Kumar A, Siddiq DM, Liao KS, Li Y, Tweardy DJ, Cai C. Nanoscale surface modification favors benign biofilm formation and impedes adherence by pathogens. Nanomedicine. 2012 Apr;8(3):261-70. doi: 10.1016/j.nano.2011.11.014. Epub 2011 Dec 23.
- Background: PubMed 17230395Trautner BW, Hull RA, Thornby JI, Darouiche RO. Coating urinary catheters with an avirulent strain of Escherichia coli as a means to establish asymptomatic colonization. Infect Control Hosp Epidemiol. 2007 Jan;28(1):92-4. doi: 10.1086/510872. Epub 2006 Dec 29.
- Background: PubMed 12736047Trautner BW, Hull RA, Darouiche RO. Escherichia coli 83972 inhibits catheter adherence by a broad spectrum of uropathogens. Urology. 2003 May;61(5):1059-62. doi: 10.1016/s0090-4295(02)02555-4.
- Background: PubMed 23551395Nelsen A, Gupta S, Trautner BW, Petersen NJ, Garza A, Giordano TP, Naik AD, Rodriguez-Barradas MC. Intention to adhere to HIV treatment: a patient-centred predictor of antiretroviral adherence. HIV Med. 2013 Sep;14(8):472-80. doi: 10.1111/hiv.12032. Epub 2013 Apr 3.
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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 Trautner, MD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
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 E. coli 83972 coated urinary catheter in people with Urinary Tract Infection, 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 4 inclusion and 14 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 Oct 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 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?
Yes. Results are posted in the registry (first posted 16 Sep 2015). 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?
Rate of UTI While Colonized With E. Coli 83972. (time frame: 0-266 days of colonization). 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 NCT00554996, which also lists 15 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 16 Oct 2015.