Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
This study has been terminated.
(Results did not meet study requirements.)
Information provided by (Responsible Party):
First received: July 12, 2012
Last updated: January 14, 2013
Last verified: January 2013
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
||Observational Model: Case Control
Time Perspective: Prospective
||Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA
Biospecimen Retention: Samples Without DNA
Primary Outcome Measures:
- Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by:
i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex).
ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion).
Retention of de-identified blood culture specimens only.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Standard of Care
- Comparison of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex.)
- Comparison to the reference method (30 ug cefoxitin disc diffusion).
KeyPath Test Group
All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test.
This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Hospital patients with Gram positive blood cultures determined to be positive with the following bottle types:
- bioMerieux BacT/Alert Standard Aerobic and Anaerobic
- bioMerieux BacT/Alert FAN Aerobic and FAN Anaerobic
Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:
- bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
- bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic
- Completion of the KeyPathTM BTA Test on the sample.
- Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.
- Samples from blood culture positives over 24 hours from alarm
- Samples deemed contaminated.
- Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01640886
|University of Arizona, Infectious Disease Research
|Tuscon, Arizona, United States, 85721 |
|UCLA Clinical Laboratory
|Los Angeles, California, United States, 90049 |
|Medical University of South Carolina
|Charleston, South Carolina, United States, 29425 |
||Dipankar Manna, Ph.D.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 12, 2012
||January 14, 2013
||United States: Institutional Review Board
Keywords provided by MicroPhage, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 27, 2016
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