A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection
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|ClinicalTrials.gov Identifier: NCT00591240|
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
|Condition or disease|
|Urinary Tract Infections Bladder, Neurogenic|
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 Type :||Observational|
|Actual Enrollment :||338 participants|
|Official Title:||A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection|
|Study Start Date :||July 2007|
|Primary Completion Date :||June 2011|
|Study Completion Date :||June 2011|
Multiplex pathogen identification.
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.
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.
- 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.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591240
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304-1290|
|Principal Investigator:||Joseph C. Liao, MD||VA Palo Alto Health Care System|