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

NCT00554996 | Completed Phase 1 Results DMC

• 1 other identifier: B4623-R
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infection

Keywords

urinary tract infection; urinary catheter; Escherichia coli; biofilm

Outcome Measures

Primary Outcomes (1)

• Rate of UTI While Colonized With E. Coli 83972.

  Rate of UTI during colonization with E. coli 83972.

  0-266 days of colonization

Study Arms (1)

E. coli 83972 coated urinary catheter

OTHER

E. coli 83972 coated urinary catheter

Device: E. coli 83972 coated urinary catheter

Interventions

E. coli 83972 coated urinary catheter DEVICE

E. coli 83972 coated urinary catheter

E. coli 83972 coated urinary catheter

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Related Publications (15)

• 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.

  PMID: 18643750 BACKGROUND

• 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.

  PMID: 20610676 BACKGROUND

• 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.

  PMID: 21030042 BACKGROUND

• 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.

  PMID: 21033708 BACKGROUND

• 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.

  PMID: 22680281 BACKGROUND

• 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. No abstract available.

  PMID: 22782200 BACKGROUND

• 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. doi: 10.3109/00365548.2012.678882. Epub 2012 Jun 10.

  PMID: 22681242 BACKGROUND

• 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. No abstract available.

  PMID: 22393148 BACKGROUND

• 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.

  PMID: 22197726 BACKGROUND

• 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. doi: 10.1086/510872. Epub 2006 Dec 29.

  PMID: 17230395 BACKGROUND

• 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. doi: 10.1016/s0090-4295(02)02555-4.

  PMID: 12736047 BACKGROUND

• 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.

  PMID: 23551395 BACKGROUND

• 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.

  PMID: 23757735 BACKGROUND

• Trautner 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.

  PMID: 24713596 BACKGROUND

• Horwitz 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.

  PMID: 26048203 RESULT

MeSH Terms

Conditions

Urinary Tract Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Limitations and Caveats

Our trial was a small study with no control group.

Results Point of Contact

• Title: Barbara Trautner, MD, PhD
• Organization: Barbara Trautner, MD, PhD

barbara.trautner@va.gov

713-440-4438

Study Officials

• Barbara Trautner, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2007
• First Posted: November 7, 2007
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 16, 2015
• Results First Posted: September 16, 2015

Record last verified: 2015-09

Locations

US (1)