A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection

VA Office of Research and Development

Status: Completed

Conditions: Urinary Tract Infections; Bladder, Neurogenic

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT00591240

B4872-R

Details and patient eligibility

About

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

Full 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.

Enrollment: 338 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients suspected or at risk for complicated urinary tract infections

Exclusion criteria

• Gross contamination of urine samples at the time of collection

Trial design

338 participants in 2 patient groups

Multiplex pathogen identification.

Description:

Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.

Antimicrobial susceptibility testing.

Description:

Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.