A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00591240
First received: December 27, 2007
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

The purpose of this proposal is clinical validation of an electrochemical biochip for rapid pathogen identification and antibiotic susceptibility determination.


Condition
Urinary Tract Infections
Bladder, Neurogenic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • detect pathogens in urine [ Time Frame: ongoing ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

urine


Estimated Enrollment: 500
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients at risk for urinary tract infections. No interventions.

Detailed Description:

Point-of-care identification of pathogens and determination of antibiotic susceptibility will significantly improve the clinical management of UTI. We have previously developed a biochip based on microfabrication technology capable of rapid detection of pathogens. The specific objectives of the current proposal are: 1) Determination of microbial constituents in spinal cord injury (SCI) patients and development of additional species-specific probes against these pathogens; 2) Development of a rapid antibiotic susceptibility and molecular pyuria assay using the electrochemical biochip; and 3) Clinical validation of the biochip as a diagnostic test for UTI.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients at risk for urinary tract infections.

Criteria

Inclusion Criteria:

  • Patients suspected or at risk for complicated urinary tract infections

Exclusion Criteria:

  • Gross contamination of urine samples at the time of collection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591240

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph C. Liao, MD VA Palo Alto Health Care System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00591240     History of Changes
Other Study ID Numbers: B4872R
Study First Received: December 27, 2007
Last Updated: November 17, 2011
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
RNA, ribosomal, 16S
Biosensing techniques
Microchip analytical procedures

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Tract Infections
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Infection

ClinicalTrials.gov processed this record on April 17, 2014