JCM Accepts, published online ahead of print on 21 October 2009

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J. Clin. Microbiol. doi:10.1128/JCM.01643-09
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Presence of Genes Encoding the Panton-Valentine Leukocidin Exotoxin is Not the Primary Determinant of Outcome in Patients with Complicated Skin and Skin Structure Infections due to Methicillin-Resistant Staphylococcus aureus: Results of a Multinational Trial

In-Gyu Bae, Giang T. Tonthat, Martin E. Stryjewski, Thomas H. Rude, Lindsay F. Reilly, Steven L. Barriere, Fredric C. Genter, G. Ralph Corey, and Vance G. Fowler Jr.^*

Duke Clinical Research Institute, and Duke University Medical Center, Durham, North Carolina; Gyeonsang National University School of Medicine, Jinju, Republic of Korea; Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Buenos Aires, Argentina; Theravance, Inc., South San Francisco, California

^* To whom correspondence should be addressed. Email: fowle003{at}mc.duke.edu.

The role of Panton-Valentine leukocidin (PVL) in determining the severity and outcome of complicated skin and skin structure infections (cSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA) is controversial. We evaluated potential associations between clinical outcome and PVL status using MRSA isolates from patients enrolled in 2 large, multinational phase 3 clinical trials assessing telavancin for the treatment of cSSSI (the ATLAS program). MRSA isolates from microbiologically evaluable patients were genotyped by pulsed-field gel electrophoresis (PFGE) and PCR for pvl and 31 other putative virulence determinants. A single baseline pathogen of MRSA was isolated from 522 microbiologically evaluable patients (25.1%) of 2,079 randomized patients. Of these MRSA isolates, 83.2% (432/519) exhibited the USA300 PFGE genotype and 89.1% (465/522) were pvl-positive. Patients with pvl-positive compared with pvl-negative MRSA were more likely to be young, North American, and present with major abscesses (P < .001 for each). Patients were significantly more likely to be cured if they were infected with pvl-positive versus pvl-negative MRSA (91.6% vs. 80.7%; P = .015). This observation remained statistically significant after adjusting for the presence of abscess, fever, leukocytosis, infection size, diabetes, patient age, or study medication received. The fnbA, cna, sdrC, map/eap, sed, seg, sei, sej, SCCmec IV, and agr II genes were also associated with clinical response (P < .05). This contemporary, international study demonstrates that pvl was not the primary determinant of outcome in patients with MRSA cSSSI.