Abstract
Objective
The aim of the study was to compare all-cause adverse events (AEs) and those caused by intravenous (IV) catheter-site complications (IVCSCs) using data from a previously published study of the use of linezolid or vancomycin for treatment of complicated skin and skin structure infections (cSSSI) suspected or proven to be caused by methicillin-resistant Staphylococcus aureus.
Methods
To examine the incidence of AEs caused by the 2 antibiotic treatments, we conducted a post hoc analysis of data from a prospective, open-label, randomized, multicenter phase 4 study. Patients were randomized to treatment with either oral (PO) or IV linezolid 600 mg every 12 hours or with IV vancomycin 15 mg/kg every 12 hours with dose adjustment as needed. Study treatment was administered for 7 to 14 days. We excluded patients with baseline bacteremia (n = 11) and those who started on PO linezolid (n = 215). We analyzed data only from patients who received at least 1 dose of IV study medication.
Results
Patient demographics and types of cSSSI were comparable among patients receiving linezolid (n = 315) and vancomycin (n = 511). Mean durations of IV therapy for patients receiving linezolid and vancomycin were 4.5 days and 7.6 days (1,418 and 3,884 patient-days, respectively). All-cause AEs were reported in 50% and 51% of patients in the linezolid and vancomycin groups, respectively; all-cause IVCSCs were reported in 2% and 7%, respectively. Treatment-related IVCSCs were reported in 1 patient in the linezolid group and 16 patients in the vancomycin group.
Conclusions
The overall rate of AEs was similar among patients receiving linezolid and vancomycin, but AEs caused by IVCSCs were more frequent among patients receiving vancomycin and rare episodes of bacteremia and sepsis were more common in the linezolid group.
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