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Trial record 18 of 605 for:    Anti-Infective Agents AND susceptibility

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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date December 27, 2007
First Posted Date January 11, 2008
Results First Submitted Date June 24, 2016
Results First Posted Date June 27, 2016
Last Update Posted Date June 27, 2016
Study Start Date July 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2016)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00591240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection
Official Title A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
urine
Sampling Method Probability Sample
Study Population Patients at risk for urinary tract infections.
Condition
  • Urinary Tract Infections
  • Bladder, Neurogenic
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2016)
338
Original Estimated Enrollment
 (submitted: January 10, 2008)
120
Actual Study Completion Date June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients suspected or at risk for complicated urinary tract infections

Exclusion Criteria:

  • Gross contamination of urine samples at the time of collection
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00591240
Other Study ID Numbers B4872-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor VA Office of Research and Development
Collaborators Not Provided
Investigators
Principal Investigator: Joseph C. Liao, MD VA Palo Alto Health Care System
PRS Account VA Office of Research and Development
Verification Date June 2016