A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

Point-of-care identification of pathogens and determination of antibiotic susceptibility will significantly improve the clinical management of urinary tract infection. 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 urinary tract infection.

Within a single protocol, two non-interventional studies were conducted at different time points to achieve the aforementioned objectives. Sensitivity and specificity of the electrochemical biosensor based assay was demonstrated in each study. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00591240
Study type	Observational
Source	VA Office of Research and Development
Contact
Status	Completed
Phase	N/A
Start date	July 2007
Completion date	June 2011

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