E. Coli for Prevention of Catheter UTI in SCI Patients

NCT00458471 | Completed Phase 1

• 1 other identifier: H-11717
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Urinary Tract Infection(UTI)

Keywords

Urinary Catheter; Spinal Cord Injury; Escherichia Coli; Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• bladder colonization and rate of urinary tract infection

Interventions

Insertion of a urinary catheter coated with benign E. coli DEVICE

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (7)

• 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.

  PMID: 1928194 RESULT

• Costerton 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.

  PMID: 10334980 RESULT

• Sprunt 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.

  PMID: 3046725 RESULT

• Stover SL, Lloyd LK, Waites KB, Jackson AB. Urinary tract infection in spinal cord injury. Arch Phys Med Rehabil. 1989 Jan;70(1):47-54.

  PMID: 2644914 RESULT

• Habash 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.

  PMID: 10471979 RESULT

• Bastable 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.

  PMID: 597710 RESULT

• Thompson 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.

  PMID: 6363727 RESULT

MeSH Terms

Conditions

Urinary Tract Infections; Spinal Cord Injuries; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Barbara W Trautner, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 10, 2007
• Study Start: November 1, 2003
• Study Completion: July 1, 2005
• Last Updated: April 10, 2007

Record last verified: 2007-04

Locations

US (1)