JAC Advance Access published online on November 1, 2002
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkf215
© 2002 by The British Society for Antimicrobial Chemotherapy
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Original Paper
1 CPL Associates, LLC, 3980
Sheridan Drive, Suite 501, Amherst, NY 14226, USA
* Corresponding author. E-mail: schentag{at}buffalo.edu.
Received 6 March 2002
; revised 25 July 2002
; accepted 21 August 2002
Objective: The incidence of infections
caused by methicillin-resistant Staphylococcus aureus continues
to increase annually. Unfortunately, only a few therapeutic agents
are available for the treatment of patients with such infections
and all of the existing drugs have limitations. A pressing need
exists, therefore, to identify new antibiotics for use in this clinical
setting. The efficacy and safety of linezolid were studied in a
compassionate use treatment programme and the results of treating
a subset of patients with S. aureus infections
are presented here. Methods: Patients received linezolid in a dosage
of 600 mg intravenously (iv) and/or orally twice daily. Clinical
and bacteriological responses were assessed after a minimum of 7
days and following completion of therapy. Results: Seven hundred and ninety-six patients
who suffered 828 episodes of infection were enrolled in the linezolid
compassionate use protocol. Of these, 183 patients received linezolid for
191 infections caused by S. aureus; in 151 cases,
patients were intolerant of vancomycin, had a mixed S.
aureus/vancomycin-resistant enterococcal infection or had no
iv access, and, in 40 cases, patients had failed to respond to treatment
with vancomycin. The median age of the patients was 57 years (range
14-93 years) and 53.9% were female. The predominant
sites of infection were as follows: bone or joint (27.2%);
skin and skin structure (25.1%); bloodstream (20.9%);
and lower respiratory tract (12.6%). The clinical success
rates in the clinically evaluable and all-treated populations were
83.9% and 62.3%, respectively, whereas the bacteriological eradication
rates were 76.9% and 70.2% in the bacteriologically
evaluable and all-treated populations, respectively. Linezolid was
well tolerated. In 76 (39.8%) of the 191 episodes of infection,
patients experienced one or more adverse events or exhibited one
or more abnormal laboratory results; in 35 (18.3%) of the
191 cases it was necessary to discontinue treatment. Gastrointestinal
tract-related symptoms (nausea, vomiting and diarrhoea) were the
most common possibly or probably related adverse events and the
most common reasons for drug discontinuation. Conclusions: Linezolid was effective and well
tolerated in patients with S. aureus infections
who were enrolled in this compassionate use protocol.
The efficacy and safety of linezolid as treatment
for Staphylococcus aureus infections in compassionate
use patients who are intolerant of,
or who have failed to respond to, vancomycin
2 CPL Associates, LLC, 3980
Sheridan Drive, Suite 501, Amherst, NY 14226, USA; School of Pharmacy,
University at Buffalo, Buffalo, NY, USA
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