NCT00371631

Brief Summary

The purpose of the research is to determine whether we can get harmless bacteria to live in the bladders of persons with spinal cord injury who practice intermittent bladder catheterization. We will also look at whether having the harmless bacteria in the bladder prevents urinary tract infections from occurring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 31, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

August 31, 2006

Results QC Date

November 13, 2014

Last Update Submit

November 20, 2014

Conditions

Spinal Cord InjuryUrinary Tract Infection

Keywords

biofilmclinical trialEscherichia coliurinary catheter

Outcome Measures

Primary Outcomes (1)

  • Bladder Colonization

    Bladder colonization was defined when (≥102 cfu/ml) of E. coli 83972 was detected in urine cultures for \> 3 days after catheter removal.

    > 3 days, up to 197 days

Secondary Outcomes (1)

  • The Rate of Symptomatic UTI While Colonized

    3 years

Study Arms (1)

Arm 1

OTHER

insertion of E. coli coated catheter

Biological: Insertion of urinary catheters coated with E. coli 83972

Interventions

Insertion of urinary catheters coated with E. coli 83972BIOLOGICAL

All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.

Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients followed at the MEDVAMC who have sustained spinal cord injury \> 12 months earlier, suffer from neurogenic bladder, practice intermittent bladder catheterization, and who have had at least 1 symptomatic UTI in the past will be enrolled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Burns AC, Petersen NJ, Garza A, Arya M, Patterson JE, Naik AD, Trautner BW. Accuracy of a urinary catheter surveillance protocol. Am J Infect Control. 2012 Feb;40(1):55-8. doi: 10.1016/j.ajic.2011.04.006. Epub 2011 Aug 3.

    PMID: 21813209RESULT

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Tract InfectionsEscherichia coli Infections

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Limitations and Caveats

Lack of placebo control.

Results Point of Contact

Title
Dr. Barbara Trautner, MD, PhD
Organization
Michael E. DeBakey Veterans Affairs
barbara.trautner@va.gov
713-440-4438

Study Officials

  • Barbara Trautner, MD

    Michael E. DeBakey VA Medical Center

    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

August 31, 2006

First Posted

September 4, 2006

Study Start

October 1, 2006

Primary Completion

February 1, 2008

Study Completion

April 1, 2008

Last Updated

November 24, 2014

Results First Posted

November 24, 2014

Record last verified: 2014-11

Locations

US(1)