Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
Stopped early
Conditions studied: Bacteremia
In brief
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.
Key facts
- Study ID
- NCT01640886
- Run by
- MicroPhage, Inc.
- People needed
- 764
- Starts
- 2012-06-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2013-01-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Arizona, Infectious Disease Research — Tuscon, Arizona, United States
- UCLA Clinical Laboratory — Los Angeles, California, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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