JAC Advance Access published online on January 16, 2004
Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkh088
© 2004 by The British Society for Antimicrobial Chemotherapy
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Original article
1 Department of Microbiology,
Leeds General Infirmary & University of Leeds Teaching
Hospitals, Old Medical School, Leeds LS1 3EX;
* Corresponding author. E-mail: markwi{at}pathology.leeds.ac.uk.
Received 15 January 2003
; revised 27 November 2003
; accepted 27 November 2003
The efficacy, safety and tolerability of linezolid
was compared with teicoplanin in a randomized, controlled, open-label,
multicentre study of 430 patients with suspected or proven Gram-positive
infection. Patients received intravenous (iv) ± oral
linezolid 600 mg every 12 h (n = 215)
or iv or intramuscular teicoplanin (n = 215)
for up to 28 days. Clinical outcomes in the intent-to-treat (ITT)
and clinically-evaluable populations and microbiological success
rates in microbiologically evaluable patients were assessed at follow-up
(test of cure). Investigator assessed clinical cure rates at end
of treatment (EOT) in ITT patients treated with linezolid (95.5%)
were superior to those of teicoplanin (87.6%) for all infections
combined, indicating a 7.9% statistically significant treatment
advantage for linezolid (P = 0.005, 95% CI:
2.5, 13.2). Clinical cure rates by baseline diagnosis were consistently
higher at EOT for the linezolid versus teicoplanin groups with skin
and soft tissue infection (96.6% versus 92.8%),
pneumonia (96.2% versus 92.9%) and bacteraemia
(88.5% versus 56.7%). The 31.8% treatment
advantage in bacteraemic patients (but not for those seen in the
other infection categories) for linezolid-treated patients was statistically
significant (P = 0.009, 95% CI:
10.2, 53.4). Bacterial eradication rates for linezolid exceeded
those of teicoplanin for all infection sites combined but this did
not reach statistical significance (81.9% versus 69.8%,
respectively; P = 0.056). Adverse event
rates were similar between the treatment groups, were mild to moderate
in severity, and resolved quickly following treatment. The linezolid
group experienced a higher incidence of drug related adverse events
(30% versus 17%; P = 0.002), and
notably of gastrointestinal effects (13.0% versus 1.9%, P = 0.001). However, antibiotic discontinuation rates
as a result of drug related adverse events were similar (4.7% in
the linezolid group versus 3.7%). Linezolid was clinically
superior to teicoplanin in the treatment of Gram-positive infections.
Keywords: glycopeptides, Gram-positive bacteria, oxazolidinones
Linezolid compared with teicoplanin for the treatment
of suspected or proven Gram-positive infections
2 Ninewells Hospital & Medical School, East
Block, Dundee;
3 Department
of Microbiology, Royal Hampshire County Hospital, Winchester, UK
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