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Trial record 18 of 601 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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Urinary Tract Infections
Bladder, Neurogenic
Enrollment 338
Recruitment Details Urine samples were collected from participants at the Spinal Cord Injury Service at Veterans Affairs Palo Alto Health Care System for assay validation.
Pre-assignment Details  
Arm/Group Title Multiplex Identification of Pathogens. Antimicrobial Susceptibility Testing.
Hide Arm/Group 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. 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.
Period Title: Overall Study
Started 116 222
Completed 116 222
Not Completed 0 0
Arm/Group Title Multiplex Identification of Pathogens. Antimicrobial Susceptibility Testing. Total
Hide Arm/Group 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 116 222 338
Hide Baseline Analysis Population Description
Research subjects recruited from spinal cord injury unit.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 222 participants 338 participants
<=18 years
0
   0.0%
NA [1]  NA [2] 
Between 18 and 65 years
100
  86.2%
NA [1]  NA [2] 
>=65 years
16
  13.8%
NA [1]  NA [2] 
[1]
Age information was not collected for Group 2: Antimicrobial susceptibility testing.
[2]
Total not calculated because data are not available (NA) in one or more arms.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 222 participants 338 participants
Female
4
   3.4%
7
   3.2%
11
   3.3%
Male
112
  96.6%
215
  96.8%
327
  96.7%
1.Primary Outcome
Title Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.
Hide Description

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.

Time Frame Up to 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Urine samples were collected from participants at the Spinal Cord Injury Service for assay validation.
Arm/Group Title Multiplex Identification of Pathogens. Antimicrobial Susceptibility Testing.
Hide Arm/Group 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.
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.
Overall Number of Participants Analyzed 116 222
Overall Number of Units Analyzed
Type of Units Analyzed: Urine specimen
109 157
Measure Type: Number
Unit of Measure: percentage of urine specimen
Biosensor sensitivity 89 92
Biosensor specificity 100 97
Negative predictive value 76 81
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not assessed as there were no interventions performed in these studies.
 
Arm/Group Title Multiplex Identification of Pathogens. Antimicrobial Susceptibility Testing.
Hide Arm/Group 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. 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.
All-Cause Mortality
Multiplex Identification of Pathogens. Antimicrobial Susceptibility Testing.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Multiplex Identification of Pathogens. Antimicrobial Susceptibility Testing.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multiplex Identification of Pathogens. Antimicrobial Susceptibility Testing.
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Joseph Liao
Organization: VA Palo Alto Health Care System
Phone: 650-493-5000 ext 65581
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00591240     History of Changes
Other Study ID Numbers: B4872-R
First Submitted: December 27, 2007
First Posted: January 11, 2008
Results First Submitted: June 24, 2016
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016