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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroPhage | Blood Culture positive specimens available within 24 hours of alarm. |
| |
| Standard of Care | Blood Culture positive specimens. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroPhage S. aureus / MSSA / MRSA Blood Culture Test (prototype) | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Blood culture positive specimens from three academic medical centers.
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| Name | Affiliation | Role |
|---|---|---|
| J D Smith, Ph.D. | MicroPhage, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evanston Northwestern Healthcare Research Institute | Evanston | Illinois | 60201 | United States | ||
| University of Maryland Baltimore |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D013203 | Staphylococcal Infections |
| D018805 | Sepsis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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Retention of discrepant blood culture specimens only.
|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Johns Hopkins Medical Institute | Baltimore | Maryland | 21287 | United States |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |