Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
NCT ID: NCT01640886
Last Updated: 2013-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
764 participants
OBSERVATIONAL
2012-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Standard of Care
1. Comparison of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex.)
2. Comparison to the reference method (30 ug cefoxitin disc diffusion).
No interventions assigned to this group
KeyPath Test Group
All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
* bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic
2. Completion of the KeyPathTM BTA Test on the sample.
3. 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.
Exclusion Criteria
2. Samples deemed contaminated.
3. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.
18 Years
ALL
No
Sponsors
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MicroPhage, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dipankar Manna, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
MicroPhage, Inc.
Locations
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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
Countries
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Other Identifiers
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MP2012-A
Identifier Type: -
Identifier Source: org_study_id
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