An interventional study of Accelerate Pheno and Standard of Care in Gram-negative Bacteremia, sponsored by Accelerate Diagnostics, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by Accelerate Diagnostics, Inc. · Not applicable, Interventional, and Diagnostic
The FDA-cleared Accelerate Pheno™ System and PhenoTest™ 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 Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.
322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.
Browse Bacteremia studies →Accelerate Diagnostics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Diagnostic Test: Accelerate Pheno
Diagnostic Test: Standard of Care
The Accelerate Pheno™ system and PhenoTest™ 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.
Standard blood culture work up as determined by the site's microbiology lab.
Desirability of Outcome Ranking (DOOR) - composite outcome
The primary endpoint is the probability that a patient will have a better DOOR when the Accelerate PhenoTest™ BC kit is used on positive blood cultures due to gram-negative rods compared to the standard of care
Time frame: 30 days
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Accelerate Diagnostics, Inc.