MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial
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|ClinicalTrials.gov Identifier: NCT00814151|
Recruitment Status : Completed
First Posted : December 24, 2008
Last Update Posted : December 24, 2008
|Condition or disease||Intervention/treatment|
|Bacteremia Staphylococcal Infection Sepsis Infection||Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)|
|Study Type :||Observational|
|Actual Enrollment :||712 participants|
|Observational Model:||Case Control|
|Official Title:||Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Blood Culture positive specimens available within 24 hours of alarm.
Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)
In vitro diagnostic: The MicroPhage "Intervention" was to perform the MicroPhage diagnostic test to detect S. aureus in the blood culture sample and determine MSSA or MRSA status at 4 and 5 hours of test incubation. The "Intervention" results were not made available to the patient or their physician.
Standard of Care
Blood Culture positive specimens.
- Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives. [ Time Frame: Within 48 hours ]
- Qualitative feedback on the preliminary MicroPhage test protocol.
- Comparative results to market-available S. aureus / MRSA tests for Blood Culture. [ Time Frame: Within 48 hours ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814151
|United States, Illinois|
|Evanston Northwestern Healthcare Research Institute|
|Evanston, Illinois, United States, 60201|
|United States, Maryland|
|University of Maryland Baltimore|
|Baltimore, Maryland, United States, 21201|
|Johns Hopkins Medical Institute|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||J D Smith, Ph.D.||MicroPhage, Inc.|