A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection

NCT00591240 | Completed Results

• 1 other identifier: B4872-R
• Study Type: observational
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Tract Infections; Bladder, Neurogenic

Keywords

RNA, ribosomal, 16S; Biosensing techniques; Microchip analytical procedures

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 1.5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at risk for urinary tract infections.

You may qualify if:

• Patients suspected or at risk for complicated urinary tract infections

You may not qualify if:

• Gross contamination of urine samples at the time of collection

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

Related Publications (2)

• Chen CH, Lu Y, Sin ML, Mach KE, Zhang DD, Gau V, Liao JC, Wong PK. Antimicrobial susceptibility testing using high surface-to-volume ratio microchannels. Anal Chem. 2010 Feb 1;82(3):1012-9. doi: 10.1021/ac9022764.

  PMID: 20055494 RESULT

• Mach KE, Du CB, Phull H, Haake DA, Shih MC, Baron EJ, Liao JC. Multiplex pathogen identification for polymicrobial urinary tract infections using biosensor technology: a prospective clinical study. J Urol. 2009 Dec;182(6):2735-41. doi: 10.1016/j.juro.2009.08.028. Epub 2009 Oct 17.

  PMID: 19837423 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

urine

MeSH Terms

Conditions

Urinary Tract Infections; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The trial is non-interventional. Future studies will focused on developing advanced prototypes with the option of using the biosensor platform to direct patient care in comparison with standard microbiology.

Results Point of Contact

• Title: Dr. Joseph Liao
• Organization: VA Palo Alto Health Care System

joseph.liao@va.gov

650-493-5000

Study Officials

• Joseph C. Liao, MD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: July 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 27, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)