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

Study Overview
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Brief Summary
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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 diagnostic platform.

Detailed Description
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This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.

Official Title
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Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.

Conditions
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Bacteremia, Staphylococcal Infection, Sepsis, Infection

Intervention / Treatment
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* Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age. Blood culture positive, of ANY of the following bottle types: BD Bactec Standard Aerobic and Anaerobic, BD Bactec Plus Aerobic and Anaerobic, bioMerieux BacT/Alert Standard Aerobic and Anaerobic, bioMerieux BacT/Alert FAN Aerobic and Anaerobic. Exclusion Criteria: BD Bactec Lytic, Pediatric, or other bottle types not listed above. bioMerieux Pediatric FAN or other bottle types listed above. Trek bottles. Specimens from patients under 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MicroPhage<br>Blood Culture positive specimens available within 24 hours of alarm. | Other: MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype)<br>* 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.<br>|
| Standard of Care<br>Blood Culture positive specimens. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives. |  | Within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative feedback on the preliminary MicroPhage test protocol. |  |  | 
| Comparative results to market-available S. aureus / MRSA tests for Blood Culture. |  | Within 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteremia, Blood culture, Staphylococcus aureus, MRSA, MSSA, MicroPhage