Potential impact of the FilmArray Multiplex PCR as compared to standard of care testing on antimicrobial therapy guidance and clinical outcomes for ventilator-associated pneumonia in critically ill patients: a two-phased, single centre study: cross-sectional retrospective observational study using collected data from the ICU and prospective, open-labelled, randomised controlled clinical trial

Abstract

Background Ventilator-associated pneumonia is common in critical care and can be life- threatening. Standard methods currently take at least 24 to 48 hours to identify the infectious etiology.

The potential severity of this infection combined with a delay in pathogen identification results in

administration of empirical broad-spectrum antibiotic agents, thus increasing the risk of multidrug- resistance acquisition and with limited assurance that the causative microorganism is being covered.

The FilmArray rapid multiplex PCR offers an alternative to address this issue by obtaining early

pathogen identification as well as associated multiresistances, which may result in early narrow- spectrum antimicrobial stewardship (therefore decreasing the development of multidrug-resistant

organisms) and clinical improvement of patients. Objectives To determine if there is concordance between molecular testing with FilmArray and standard of care testing with conventional culture in pathogen detection and to determine if the use of FilmArray in ventilator-associated pneumonia allows an early start of appropriate targeted antibiotic treatment, improving the clinical outcome of patients. Study participants The participants included in the study will be critically ill adults (≥18 years) diagnosed with ventilator-associated pneumonia being treated in the ICU of Santa Caterina Hospital and able to provide sufficient volume of airway specimen obtained for routine cultures and FilmArray. Design and methods This is a two-phased, single-centre study that will be conducted in the ICU of Santa Caterina Hospital. The first phase will be a cross-sectional retrospective observational study, that will consist in reviewing the results of respiratory samples from patients diagnosed with VAP, which have been analysed in parallel with conventional culture and FilmArray, to determine the concordance between both techniques. The second phase will be a prospective, open-labelled, randomised controlled clinical trial, that will consist in enrolling 200 patients through consecutive sampling, and randomly assigning them in a ratio 1:1 to a control group, who will be diagnosed with conventional culture and treated according to its results, and to an intervention group, who will be diagnosed with FilmArray plus conventional culture and will be treated according to FilmArray results. The time of intervention will be of 4 years. Independent outcome assessors will be in charge of drawing the conclusions of the study