Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study

This study has suspended participant recruitment.

(FDA has approved our request to put trial on clinical hold because human subjs "are or would be exposed to an unreasonable & significant risk of illness/injury")

Sponsor:

Information provided by (Responsible Party):

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00554996

First received: November 5, 2007

Last updated: April 18, 2014

Last verified: April 2014

History of Changes

Purpose

This study is a prospective pilot clinical trial investigating the use of urinary catheters coated with benign E. coli in geriatric subjects.

Condition	Intervention	Phase
Urinary Tract Infection	Device: E. coli 83972 coated urinary catheter	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Bacterial Interference for Prevention of Catheter-Associated UTI

Resource links provided by NLM:

MedlinePlus related topics: Urinary Tract Infections

Drug Information available for: Escherichia coli

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

Safety--lack of symptoms attributable to study catheter or bladder colonization with E. coli 83972. Rate of UTI while colonized with E. coli 83972. [ Time Frame: during 1-3 months of bladder colonization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of UTI while colonized with E. coli 83972 [ Time Frame: during 1-3 months of bladder colonization ] [ Designated as safety issue: No ]


Estimated Enrollment:	25
Study Start Date:	August 2012
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1	Device: E. coli 83972 coated urinary catheter E. coli 83972 coated urinary catheter

Show Detailed Description

Eligibility


Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

obstructive urolithiasis
percutaneous nephrostomy catheters
supravesicular urinary diversion
vesicoureteral reflux
active malignancy
uncontrolled diabetes mellitus
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554996

Locations


United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Department of Veterans Affairs

Investigators


Principal Investigator:	Barbara Trautner, MD	Michael E DeBakey VA Medical Center

More Information

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.

Buscher 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.

Desai 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.

Qin 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.

Nelsen 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.

Trautner 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.

Roig 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. Epub 2012 Jun 10.

Gupta 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. Review.

Trautner 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.

Trautner 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. Epub 2006 Dec 29.

Trautner BW, Hull RA, Darouiche RO. Escherichia coli 83972 inhibits catheter adherence by a broad spectrum of uropathogens. Urology. 2003 May;61(5):1059-62.

Nelsen 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.

Marschall 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. Review. Erratum in: BMJ. 2013;347:f5325.


Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00554996 History of Changes
Other Study ID Numbers:	B4623-R
Study First Received:	November 5, 2007
Last Updated:	April 18, 2014
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:


urinary tract infection urinary catheter Escherichia coli biofilm

Additional relevant MeSH terms:


Urinary Tract Infections Infection Urologic Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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