This article appears in the following Journal of Antimicrobial Chemotherapy issue: Tigecycline, a therapeutic option from a new antimicrobial class (the glycylcyclines) in an era of increasing resistance [View the issue table of contents]
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Efficacy and safety of tigecycline compared with vancomycin or linezolid for treatment of serious infections with methicillin-resistant Staphylococcus aureus or vancomycin-resistant enterococci: a Phase 3, multicentre, double-blind, randomized study
1 Emergency Clinical Hospital, Bucharest, Romania 2 Multiprofile Hospital for Active Treatment, Plovdiv, Bulgaria 3 Klaipeda Seamen's Hospital, Klaipeda, Lithuania 4 St Vincent's Hospital, Indianapolis, IN, USA 5 Multiprofile Hospital for Active Treatment and Emergency Medicine, Sofia, Bulgaria 6 Wyeth Research, Collegeville, PA, USA 7 Wyeth Research, Paris, France
* Corresponding author. Tel: +1-484-865-8818; Fax: +1-484-865-9262; E-mail: babinct{at}wyeth.com
Introduction: Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) are causing serious nosocomial infections. Tigecycline was evaluated in hospitalized patients with MRSA or VRE infection.
Patients and methods: A randomized (3:1), double-blind, multicentre, Phase 3 study compared the safety and efficacy of tigecycline with vancomycin or linezolid in hospitalized patients with MRSA or VRE infection, respectively. Patients were treated for 7–28 days and the test-of-cure (TOC) assessment was made 12–37 days after the last dose. The primary efficacy endpoint was the clinical response (cure, failure and indeterminate) in the co-primary, microbiologically evaluable (ME) and microbiologically modified intent-to-treat (m-mITT) populations at the TOC assessment.
Results: For MRSA infection, clinical cure rates in the ME population (n = 117) were 81.4% (70 of 86 patients) with tigecycline and 83.9% (26 of 31 patients) with vancomycin. In the m-mITT population (n = 133), clinical cure occurred in 75 of 100 tigecycline-treated patients (75.0%) and in 27 of 33 vancomycin-treated patients (81.8%). In patients with complicated skin and skin structure infections caused by MRSA, cure rates were similar with tigecycline or vancomycin (86.4% versus 86.9% in ME population; and 78.6% versus 87.0% in m-mITT population). In patients with MRSA infection, nausea or vomiting occurred more frequently with tigecycline than with vancomycin (41.0% versus 17.9%); most cases were mild, with only three patients discontinuing treatment. In patients with VRE (total enrolment, 15), 3 of 3 and 3 of 8 patients in the ME and m-mITT populations, respectively, were cured by tigecycline, compared with 2 of 3 patients in the ME and m-mITT populations treated with linezolid.
Conclusions: Tigecycline is safe and effective in hospitalized patients with serious infection caused by MRSA. There were too few cases of VRE to draw any conclusions.
Keywords: antibiotic , glycylcycline , resistant pathogen , antimicrobial resistance , adverse events
Present address: e2g Biopharmaceutical Consulting, 994 Skelp Level Road, Downingtown, PA 19335, USA.
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