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Results did not meet study requirements.
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In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care |
| ||
| KeyPath Test Group | All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA | A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by: i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex). ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion). | 3-4 months |
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Inclusion Criteria:
Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:
Completion of the KeyPathTM BTA Test on the sample.
Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.
Exclusion Criteria:
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Hospital patients with Gram positive blood cultures determined to be positive with the following bottle types:
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| Name | Affiliation | Role |
|---|---|---|
| Dipankar Manna, Ph.D. | MicroPhage, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona, Infectious Disease Research | Tuscon | Arizona | 85721 | United States | ||
| UCLA Clinical Laboratory |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D013203 | Staphylococcal Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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Retention of de-identified blood culture specimens only.
| Los Angeles |
| California |
| 90049 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |