Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates

Study Overview
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Brief Summary
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This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Detailed Description
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This clinical study entitled Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017. Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens. The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB). It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Official Title
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Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System With New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens

Conditions
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Bacteremia

Intervention / Treatment
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* Device: Specimens that meet inclusion criteria


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system Positive blood culture sample containing gram-negative rods according to Gram stain results For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded A minimum sample volume of 2.0 mL Seeded blood culture specimens derived from archived bacterial Exclusion Criteria: Blood culture positivity is > 8 hours prior to initiation of testing with the Accelerate Pheno™ system Insufficient (less than 2.0 mL) remnant sample volume From a patient that has already been enrolled in the study Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Specimens that meet inclusion criteria<br> | Device: Specimens that meet inclusion criteria<br>* Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method |  | Approximately 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results |  | Approximately 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positive blood culture