Effectiveness of the BioFire FilmArray for the rapid detection of bloodstream infection in haematological patients with febrile neutropenia (the ONFIRE study): study protocol of a prospective, multicentre observational study at three reference university hospitals in Spain.

introductionBloodstream infection (BSI) due to multidrug-resistant Gram-negative bacilli is a serious global health problem that has a profound impact on severely immunosuppressed neutropenic haematological patients. Prompt institution of appropriate antimicrobial therapy is crucial for improving outcomes in these patients, and in an era of multidrug resistance, antimicrobial stewardship programmes are mandatory. Blood cultures, the current gold standard for the diagnosis of BSI, present two main drawbacks: the prolonged time to results and their low sensitivity, especially if the patient has received antimicrobial treatment before blood extraction. The aim of this study is to determine whether a molecular technique, the BioFire FilmArray Blood Culture Identification 2 (BCID2) panel, achieves higher sensitivity and specificity than conventional blood cultures for the microbiological diagnosis of BSI in haematological patients with febrile neutropenia. METHODS AND ANALYSIS: This multicentre, prospective, observational study will be conducted at three reference university hospitals in Spain. The population will comprise haematological patients scheduled to undergo diagnostic blood cultures as standard care for the microbiological diagnosis of the febrile neutropenia episode. The BioFire FilmArray panel will be performed in patients with positive blood cultures at the time of blood culture positivity and in patients with negative blood cultures at 48 hours of incubation. The primary endpoint will be the sensitivity and specificity of the BioFire FilmArray BCID2 panel compared with conventional blood cultures. The secondary endpoints will be this same comparison in the subgroup of patients with recent (<48 hour) or concomitant use of systemic antibiotics and comparison of BioFire FilmArray and conventional blood cultures in terms of identifying time to antibiotic resistance. ETHICS AND DISSEMINATION: The study protocol has been approved by the Clinical Research Ethics Committee at Bellvitge Hospital (reference number ICPS029/22) and the Institutional Review Boards at each participating site. All patients' personal data will be processed, disclosed and transferred in accordance with Organic Law 3/2018 of 5 December 2018 and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016. All data will be collected, stored and processed anonymously. Results will be reported at conferences and in peer-reviewed publications regardless of whether the hypothesis is demonstrated. Any formal presentation or publication of data collected from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors. DISCUSSION: The aim of this study is to assess the impact of the BCID2 panel on the diagnostic yield of BSI in haematological patients with febrile neutropenia. Unlike previous studies, which focused on patients with documented BSI, our research will include all patients with febrile neutropenia. TRIALS REGISTRATION NUMBER: NCT06787326.