MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial
|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
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.|