Efficacy and tolerability of linezolid in treating severe skin and soft tissue infections caused by gram-positive pathogens

Background and Purpose: Linezolid, an oxazolidonone, has shown efficacy in the treatment of adults with nosocomial or community-acquired pnemonia; skin and soft tissue infections and infections due to methicillin-resistant Staphylococcus aureus. The purpose of this open-label, single-arm, multicenter study was to evaluate the efficacy and tolerability of linezolid in patients from the Asia-Pacific Region with severe Gram-positive skin and soft tissue infections. Methods: 166 patients at 27 sites in 7 countries from the Asia-Pacific region were enrolled. The patients has severe skin infection involving the deeper layers or extensive surface area. Patients received 7 to 28 days of treatment with linezolid by clinical judgment. All patient received intravenous linezolid 600 mg twice a day initially and were switched over to an equivalent oral dose (60 mg twice a day) when the investigator discerned clinical improvement. The primary efficacy endpoint in this study was clinical outcome at the follow-up visit, 14 to 21 days after completion of treatment (test of cure), and the secondary efficacy variable was microbiologic response at test-of cure. Results: 166 patients received the study medication and were included in the intent-to-treat analysis. The clinical success rate was approximately 93% in both the intern-to-treat and clinically evaluable populations at the end of treatment and test-of-cure visits. In the modified intent-to-treat and microbiologically evaluable populations, the microbiologic success rates at the test-of cure visit were 88.9% and 93.8%, respectively. The most frequent treatment-emergent adverse events were nausea (13%), dizziness (8%), anemia (7%), and vomiting (5%). Conclusions: Linezolid was effective and well tolerated in patients with severe skin and soft tissue infections caused by Gram-positive pathogens.