Status:
COMPLETED
Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
Lead Sponsor:
MicroPhage, Inc.
Conditions:
Bacteremia
Eligibility:
All Genders
18+ years
Brief Summary
Direct in-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnos...
Detailed Description
This is a multi-center, FDA clinical study designed to investigate the safety and performance of the MicroPhage S. aureus/MSSA/MRSA test direct from blood culture positives. Informed consent is not an...
Eligibility Criteria
Inclusion
- Blood culture positive samples from subjects aged 18+, with any of the following bottle types:
- BD Bactec Standard Aerobic and Anaerobic,
- BD Bactec Plus Aerobic and Anaerobic,
- Completion of the MicroPhage test protocol on the sample.
Exclusion
- Samples from subjects under 18 years of age,
- Samples from any other not included bottle types,
- Samples from blood culture positives over 24 hours from alarm,
- Samples deemed contaminated,
- Mislabeled / misidentified samples or data without documented corrections,
- Violations and/or deviations from the MicroPhage test protocol and/or other included test protocols under study.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
1165 Patients enrolled
Trial Details
Trial ID
NCT01184339
Start Date
August 1 2009
End Date
August 1 2010
Last Update
August 18 2010
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