Trial Outcomes & Findings for A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection (NCT NCT00591240)
NCT ID: NCT00591240
Last Updated: 2016-06-27
Results Overview
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.
COMPLETED
338 participants
Up to 1.5 years
2016-06-27
Participant Flow
Urine samples were collected from participants at the Spinal Cord Injury Service at Veterans Affairs Palo Alto Health Care System for assay validation.
Participant milestones
| Measure |
Multiplex Identification of Pathogens.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
116
|
222
|
|
Overall Study
COMPLETED
|
116
|
222
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection
Baseline characteristics by cohort
| Measure |
Multiplex Identification of Pathogens.
n=116 Participants
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.
n=222 Participants
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
n=338 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=39 Participants
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=39 Participants
|
NA Participants
n=41 Participants
|
NA Participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=39 Participants
|
215 Participants
n=41 Participants
|
327 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Up to 1.5 yearsPopulation: Urine samples were collected from participants at the Spinal Cord Injury Service for assay validation.
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.
Outcome measures
| Measure |
Multiplex Identification of Pathogens.
n=109 Urine specimen
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.
n=157 Urine specimen
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.
Biosensor sensitivity
|
89 percentage of urine specimen
|
92 percentage of urine specimen
|
|
Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.
Biosensor specificity
|
100 percentage of urine specimen
|
97 percentage of urine specimen
|
|
Clinical Validation of Biosensor Assays Used for Pathogen Identification and Antimicrobial Susceptibility Testing in Patients at Risk of Urinary Tract Infections.
Negative predictive value
|
76 percentage of urine specimen
|
81 percentage of urine specimen
|
Adverse Events
Multiplex Identification of Pathogens.
Antimicrobial Susceptibility Testing.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place