Ceftolozane/tazobactam for treatment of severe ESBL-producing enterobacterales infections: A multicenter nationwide clinical experience (CEFTABUSE II Study)

Abstract

Background: Few data are reported in the literature about the outcome of patients with severe extended-spectrum ß-lactamase-producing Enterobacterales (ESBL-E) infections treated with cefolozane/tazobactam (C/T), in empiric or defnitive therapy. Methods: A multicenter retrospective study was performed in Italy (June 2016-June 2019). Successful clinical outcome was defined as complete resolution of clinical signs/symptoms related to ESBL-E infection and lack of microbiological evidence of infection. The primary end point was to identify predictors of clinical failure of C/T therapy. Results: C/T treatment was documented in 153 patients: pneumonia was the most common diagnosis (n = 46, 30%), followed by 34 cases of complicated urinary tract infections (22.2%). Septic shock was observed in 42 (27.5%) patients. C/T was used as empiric therapy in 46 (30%) patients and as monotherapy in 127 (83%) patients. Favorable clinical outcome was observed in 128 (83.7%) patients; 25 patients were considered to have failed C/T therapy. Overall, 30-day mortality was reported for 15 (9.8%) patients. At multivariate analysis, Charlson comorbidity index >4 (odds ratio [OR], 2.3; 95% confidence interval [CI], 1.9-3.5; P =.02), septic shock (OR, 6.2; 95% CI, 3.8-7.9; P