Efficacy and tolerability of linezolid in treating severe skin and soft tissue infections caused by Gram-positive pathogens.
OBJECTIVE
Linezolid, an oxazolidinone, has shown efficacy in the treatment of adults with nosocomial or community-acquired pneumonia; 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 had 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 patients received intravenous linezolid 600 mg twice a day initially and were switched over to an equivalent oral dose (600 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 intent-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.
Chen
Yao-Shen
YS
Kaohsiung Veterans General Hospital, Graduate Institute of Environmental Education, National Kaohsiung Normal University, Kaohsiung, Taiwan.
Lee
Sai-Cheong
SC
Kim
Woo-Joo
WJ
D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002481:Cellulitis / Q000188:drug therapy / Q000382:microbiology; D003257:Consumer Product Safety; D005260:Female; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy*; D006801:Humans; D000069349:Linezolid; D008297:Male; D008875:Middle Aged; D023303:Oxazolidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011500:Protein Synthesis Inhibitors / Q000627:therapeutic use*; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D018461:Soft Tissue Infections / Q000188:drug therapy*
D000081:Acetamides; D023303:Oxazolidinones; D011500:Protein Synthesis Inhibitors; D000069349:Linezolid