NCT00309114

Brief Summary

Urinary tract infection (UTI) is the most common infection in patients with spinal cord injury (SCI) and is linked to major undesired results or complications including death. The bladder of SCI patients, especially those with indwelling catheters, is usually colonized by bacteria, some of which do and others which do not cause symptoms of UTI. Bacteria that do not cause symptoms are often called benign colonizers and are often left untreated because they may provide some protection against infection with more harmful bacteria. This idea of using benign bacteria to prevent infections with symptoms is called bacterial interference. A prototype strain, Escherichia coli 83972, was shown to begin and continue for extended periods of time non symptom causing colonization of the human bladder and to hold back symptom causing infections of the neurogenic bladder. Data from pilot studies at two medical centers indicated that bacterial interference might be a useful therapy for reducing the rate or frequency of UTI in SCI patients. Because almost all SCI patients have a UTI at some time, and also the large costs of treating this infection, studying the impact of bladder colonization with E. coli 83972 on the rate of symptom causing UTI has an amazing potential for improving the quality of life of SCI patients and decreasing the cost of health care. Like with other preventive plans such as vaccination, for instance, it is important to explore the effectiveness of this new preventive approach. The project is a prospective, randomized, double blind, multi-center study that deals with specific pieces of bacterial interference in SCI patients. HYPOTHESES: Placing non symptom causing bacteria (E. coli 83972) into SCI patients' bladders reduces the rate of symptom causing UTI. A. SPECIFIC AIM: Determine how bladder colonization with E. coli 83972 or similar bacteria affects the rate of symptom causing urinary tract infections in a large group of SCI and Spina Bifida patients by conducting a prospective, randomized, placebo-controlled, multi-center clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

5.8 years

First QC Date

March 30, 2006

Last Update Submit

February 21, 2017

Conditions

Urinary Tract Infections

Keywords

UTISCIE coliPrevention

Outcome Measures

Primary Outcomes (1)

  • Putting E. coli 83972 into the bladder of SCI patients reduces the rate of symptomatic UTI.

    12 Months

Secondary Outcomes (1)

  • Study the affect of bladder colonization with E. coli 83972 on the rate of symptom causing UTI in a large group of SCI and Spina Bifida patients.

    12 Months

Study Arms (2)

Interventions for Experimental Arm

EXPERIMENTAL

Bacterial Interference with Escherichia coli 83972. Each bladder inoculation contains the study organism, E. coli 83972, suspended as a clear solution in sterile physiological saline.

Procedure: bacterial interference

Interventions for Control Arm

PLACEBO COMPARATOR

Each bladder inoculation contains sterile physiological saline that does not contain the study organism.

Procedure: bacterial interference

Interventions

bacterial interferencePROCEDURE
Interventions for Control ArmInterventions for Experimental Arm

Eligibility Criteria

Age15 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years or older
  • Living in institutional or non-institutional settings
  • months post spinal cord injury (SCI) prior to entry or have Spina Bifida
  • Loss of bladder function
  • Loss of normal bladder sensation
  • Selected in-patients involved in the Rehab I program
  • Catheter dependent, having either an indwelling urinary catheter or using an external catheter, intermittent catheterization, or vesical urinary diversion (original bladder, whole or in part, serves as the collection receptacle for urine) for bladder management.
  • Two or more urinary tract infections (UTI) within the 12 months prior to the study.
  • Capable of understanding the purpose of the study and providing informed consent to participate
  • Pursue appropriate follow-up over the course of the study.

You may not qualify if:

  • Any bladder stone(s)
  • Kidney stone(s) greater than 1 cm in size
  • Any obstructing kidney stone regardless of size
  • Nephrostomy tube(s)
  • Supravesical diversion (original bladder is no longer part of the collection receptacle for urine)
  • Congenital genitourinary anomaly that predisposes to UTI
  • Conditions anticipated to require recurrent antibiotic therapy for extraurogenital infection (e.g., recurrent pneumonia, decubitus ulcer)
  • Current immunosuppression
  • Vascular prosthesis
  • Congenital or acquired cardiac disease susceptible to vegetative infections
  • Bladder capacity of less than 50 cc
  • Individuals with known significant cognitive impairment resulting from trauma, disease, or congenital conditions
  • Women of childbearing age who engage in unprotected intercourse
  • Women who are currently pregnant will be included in the study
  • Women who become pregnant during the study will be discontinued from participation. Pregnant women who experience UTI or prolonged asymptomatic bacteriuria are at risk of bearing infants with low birth weight.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

Rehab Institute Chicago

Chicago, Illinois, 60611, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Michael E Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

The Institute for Rehabilitation and Research (TIRR)

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Darouiche RO, Thornby JI, Cerra-Stewart C, Donovan WH, Hull RA. Bacterial interference for prevention of urinary tract infection: a prospective, randomized, placebo-controlled, double-blind pilot trial. Clin Infect Dis. 2005 Nov 15;41(10):1531-4. doi: 10.1086/497272. Epub 2005 Oct 13.

    PMID: 16231269BACKGROUND

  • Darouiche RO, Donovan WH, Del Terzo M, Thornby JI, Rudy DC, Hull RA. Pilot trial of bacterial interference for preventing urinary tract infection. Urology. 2001 Sep;58(3):339-44. doi: 10.1016/s0090-4295(01)01271-7.

    PMID: 11549475BACKGROUND

  • Hull R, Rudy D, Donovan W, Svanborg C, Wieser I, Stewart C, Darouiche R. Urinary tract infection prophylaxis using Escherichia coli 83972 in spinal cord injured patients. J Urol. 2000 Mar;163(3):872-7.

    PMID: 10687996BACKGROUND

  • Darouiche RO, Green BG, Donovan WH, Chen D, Schwartz M, Merritt J, Mendez M, Hull RA. Multicenter randomized controlled trial of bacterial interference for prevention of urinary tract infection in patients with neurogenic bladder. Urology. 2011 Aug;78(2):341-6. doi: 10.1016/j.urology.2011.03.062. Epub 2011 Jun 17.

    PMID: 21683991RESULT

MeSH Terms

Conditions

Urinary Tract InfectionsEscherichia coli Infections

Interventions

Antibiosis

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Microbial InteractionsMicrobiological PhenomenaBiological Phenomena

Study Officials

  • Rabih Darouiche, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Barbara Trautner, MD, PhD

    Baylor College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Active intervention that includes bacterial interference using E. coli 83972 is compared with a placebo intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

February 1, 2004

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)