Impact of Automated Blood Culture Systems on the Management of Bloodstream Infections: Results from a Crossover Diagnostic Clinical Trial
Ana Verónica Halperín, Juan Antonio Castillo-Polo, José Luis Cortes-Cuevas, María José Cardenas Isasi, Mario Ampuero Morisaki, Robert Birch, Ana María Sánchez‐Díaz, Rafael Cantón
Abstract
Bloodstream infections are associated with high rates of morbidity and mortality. Blood culture remains the gold standard for its diagnosis. While the identification of the pathogen and its antibiotic susceptibility is required to confirm the optimal antimicrobial regimen, reductions in the times to the detection of positivity and reporting of Gram stain results may be important and time-saving to reduce inappropriate antimicrobial use, improve patient outcomes, and decrease health care costs. We report the first clinical diagnostic study of this scale in a "real-world" setting with a crossover design, comparing two automatic blood culture incubators using samples from patients with a suspected diagnosis of bacteremia/sepsis, as opposed to spiked vials. Our study design mimics that of clinical trials performed for drug marketing authorization, but patient randomization was replaced with the crossover design. A shorter time to detection could have an important effect on the faster identification of causative microorganisms of BSIs and antimicrobial stewardship.