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No sites identified with IRB approval
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The FDA-cleared Accelerate Phenoâ„¢ System and PhenoTestâ„¢ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Phenoâ„¢ System and PhenoTestâ„¢ BC Kit or processing per the site's standard of care (SOC) procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pheno | Active Comparator |
| |
| Standard of Care | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerate Pheno | Diagnostic Test | The Accelerate Phenoâ„¢ system and PhenoTestâ„¢ BC Kit is a fully-integrated in vitro diagnostic system. It is FDA-cleared to perform ID of bacteria and yeast in less than 90 minutes and AST in less than 7 hours, on average, directly from positive blood culture. |
| Measure | Description | Time Frame |
|---|---|---|
| Desirability of Outcome Ranking (DOOR) - composite outcome | The primary endpoint is the probability that a patient will have a better DOOR when the Accelerate PhenoTestâ„¢ BC kit is used on positive blood cultures due to gram-negative rods compared to the standard of care | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Standard of Care | Diagnostic Test | Standard blood culture work up as determined by the site's microbiology lab. |
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