Objectives: In this study we investigated the rate of susceptibility testing discrepancies between semi-automated and reference systems with carbapenem-resistant Enterobacterales (CRE) and the impact of alleged errors by semi-automated systems on guiding targeted therapy for CRE bloodstream infection (BSI). Methods: This was a multicentre, retrospective study enrolling patients with monomicrobial BSI caused by CRE from January 2013 to December 2016. Nonduplicate isolates from index blood cultures tested locally with semi-automated systems were centralized at a referral laboratory and retested with a reference broth microdilution or agar dilution method. Results: We enrolled 366 patients with CRE-BSI; 220 (60%) were male, and the median age was 67 years (interquartile range, 54-76 years). When compared with the results of the reference methods, those of the semi-automated systems exhibited variable rates of very major errors (VMEs; i.e. false susceptibil-ities) and major errors (MEs; i.e. false resistances). The highest rates of VMEs were observed with fos-fomycin (14%) and colistin (13.9%), and the highest rates of MEs were observed with gentamicin (21%), fosfomycin (7.7%), and tigecycline (34%). Overall, VMEs and MEs led clinicians to prescribe or confirm ineffective therapy in 25 of 341 patients (7%). Receipt of ineffective therapy supported by a misleading susceptibility test was associated with higher 30-day mortality rates by Kaplan-Meier survival curves rates compared with receipt of active therapy (56% vs. 26%; p 1/4 0.002), and the difference was confirmed after adjustment for confounders in a Cox regression model (adjusted hazard ratio: 2.91; 95% CI, 1.62-5.22; p < 0.001). Discussion: MEs and VMEs were relatively common with semi-automated susceptibility testing systems. VMEs were associated with inappropriate use of antibiotics and poorer outcomes. (C) 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Clinical consequences of very major errors with semi-automated testing systems for antimicrobial susceptibility of carbapenem-resistant Enterobacterales / Bartoletti, Michele; Antonelli, Alberto; Bussini, Linda; Corcione, Silvia; Giacobbe, Daniele Roberto; Marconi, Lorenzo; Pascale, Renato; Dettori, Silvia; Shbaklo, Nour; Ambretti, Simone; Gaibani, Paolo; Giani, Tommaso; Coppi, Marco; Bassetti, Matteo; De Rosa, Francesco Giuseppe; Marchese, Anna; Cavallo, Rossana; Lewis, Russell; Rossolini, Gian Maria; Viale, Pierluigi; Giannella, Maddalena. - In: CLINICAL MICROBIOLOGY AND INFECTION. - ISSN 1469-0691. - ELETTRONICO. - 28:(2022), pp. 0-0. [10.1016/j.cmi.2022.03.013]

Clinical consequences of very major errors with semi-automated testing systems for antimicrobial susceptibility of carbapenem-resistant Enterobacterales

Antonelli, Alberto;Giani, Tommaso;Coppi, Marco;Rossolini, Gian Maria;
2022

Abstract

Objectives: In this study we investigated the rate of susceptibility testing discrepancies between semi-automated and reference systems with carbapenem-resistant Enterobacterales (CRE) and the impact of alleged errors by semi-automated systems on guiding targeted therapy for CRE bloodstream infection (BSI). Methods: This was a multicentre, retrospective study enrolling patients with monomicrobial BSI caused by CRE from January 2013 to December 2016. Nonduplicate isolates from index blood cultures tested locally with semi-automated systems were centralized at a referral laboratory and retested with a reference broth microdilution or agar dilution method. Results: We enrolled 366 patients with CRE-BSI; 220 (60%) were male, and the median age was 67 years (interquartile range, 54-76 years). When compared with the results of the reference methods, those of the semi-automated systems exhibited variable rates of very major errors (VMEs; i.e. false susceptibil-ities) and major errors (MEs; i.e. false resistances). The highest rates of VMEs were observed with fos-fomycin (14%) and colistin (13.9%), and the highest rates of MEs were observed with gentamicin (21%), fosfomycin (7.7%), and tigecycline (34%). Overall, VMEs and MEs led clinicians to prescribe or confirm ineffective therapy in 25 of 341 patients (7%). Receipt of ineffective therapy supported by a misleading susceptibility test was associated with higher 30-day mortality rates by Kaplan-Meier survival curves rates compared with receipt of active therapy (56% vs. 26%; p 1/4 0.002), and the difference was confirmed after adjustment for confounders in a Cox regression model (adjusted hazard ratio: 2.91; 95% CI, 1.62-5.22; p < 0.001). Discussion: MEs and VMEs were relatively common with semi-automated susceptibility testing systems. VMEs were associated with inappropriate use of antibiotics and poorer outcomes. (C) 2022 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
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Bartoletti, Michele; Antonelli, Alberto; Bussini, Linda; Corcione, Silvia; Giacobbe, Daniele Roberto; Marconi, Lorenzo; Pascale, Renato; Dettori, Silvia; Shbaklo, Nour; Ambretti, Simone; Gaibani, Paolo; Giani, Tommaso; Coppi, Marco; Bassetti, Matteo; De Rosa, Francesco Giuseppe; Marchese, Anna; Cavallo, Rossana; Lewis, Russell; Rossolini, Gian Maria; Viale, Pierluigi; Giannella, Maddalena
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2158/1287045
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