A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection

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

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Key information

Conditions

Urinary Tract Infections Bladder, Neurogenic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients suspected or at risk for complicated urinary tract infections

Exclusion criteria

Gross contamination of urine samples at the time of collection

Treatment and study plan

Primary outcomes

Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.

Time frame: Up to 1.5 years

Study 1: Multiplex pathogen identification using biosensor based assay. We recruited 116 participants yielding 109 urine samples suitable for analysis and comparison between biosensor assays and standard urine culture. Biosensor based assays were used to detect multiple pathogens in the urine samples.

Study 2: Antimicrobial susceptibility testing using biosensor based assay. We recruited 222 participants yielding 252 urine samples. Corresponding biosensor and clinical microbiology culture data was available for 215 samples. 73% (157) of these samples contained bacteria. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Jan 11, 2008
Registry last updated: Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed