This is a prospective, multi-center (approximately 6 sites, at least 4 in the U.S. and 2 in the EU) study that will be conducted to evaluate the performance of the BACTEC FXI culture system and demonstrate the safety and efficacy of the instrument. Blood samples are collected in the ED from patients suspected of having a blood infection. We will enroll 700 patients at our site. We ask the patients if they consent to have an extra set of blood cultures drawn so we may assess the results in the BACTEC FXI Culture System. The BD blood culture vials are placed into the instrument in the microbiology lab for incubation and testing. We will review the charts and lab results of the recruited participants, but they will not have any follow up visits. The instrument aims to improve blood culture detection and processing metrics, making laboratory testing easier and more efficient and ultimately improving patient outcomes. The primary objective is to demonstrate the substantial equivalence of the BACTEC FXI Culture System to the BACTEC FX for each media type tested with blood cultures. This study also aims to evaluate its reproducibility.
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What is the full name of this clinical trial?
Evaluation of the Performance of BD BACTECTM FXI Culture System vs BD BACTECTM FX in the Detection of Bloodstream Infections