NCT00591240

A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 338 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Urinary Tract Infections
• Bladder, Neurogenic

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-01-11
• Last updated: 2016-06-27
• Results posted: 2016-06-27

Locations

1 site across 1 country: United States