Clinical efficacy and safety of linezolid in intensive care unit patients.

Background: To characterize the population of critically ill patients and infections treated with linezolid in the intensive care unit (ICU), and to evaluate the clinical efficacy and safety of linezolid therapy.

Methods: This multi-center, observational, real-world study was conducted across 52 hospitals between June 9, 2018, and December 28, 2019. Patients who met the following inclusion criteria were included: (1) admitted to the ICU, (2) of any age group, and (3) having a clinical or laboratory diagnosis of a Gram-positive bacterial infection. Clinical efficacy was categorized as success (cured or improved), failed, or non-evaluable. Adverse events and serious adverse events were recorded during treatment.

Results: A total of 366 ICU patients who met the inclusion criteria were evaluated. Linezolid was used as second- and first-line treatment in 232 (63.4%) and 134 (36.6%) patients, respectively. The most common isolated strain was (methicillin-resistant =37/119, 31.1%; methicillin-susceptible =15/119, 12.6%); this was followed by (vancomycin-resistant =8/119, 6.7%; vancomycin-susceptible =11/119, 9.2%) and (multidrug-resistant: =4/119, 3.4%; non-multidrug resistant: =2/119, 1.7%). The main infection sites where pathogens were detected included the lung (=216/366, 59.6%), skin and soft tissue (=104/366, 28.4%), and blood (=50/366, 13.7%). Clinical success was achieved in 301 (82.2%) patients; 34 (9.3%) were cured and 267 (73.0%) improved; treatment failure and non-evaluable outcomes were observed in 29 (7.9%) in 36 (9.8%) patients, respectively. Linezolid-related adverse events were reported in 8 (2.2%) patients. No treatment-related serious adverse events were reported.

Conclusions: Based on real-world results, linezolid was found to be effective and safe in the treatment of Gram-positive bacterial infections in critically ill patients.