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Antimicrobial Agents and Chemotherapy, November 2005, p. 4658-4666, Vol. 49, No. 11
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.11.4658-4666.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Safety and Efficacy of Tigecycline in Treatment of Skin and Skin Structure Infections: Results of a Double-Blind Phase 3 Comparison Study with Vancomycin-Aztreonam

Johannes Breedt,^1* Jüri Teras,² Janis Gardovskis,³ Frans Jacobus Maritz,⁴ Tiit Vaasna,⁵ Douglas Patrick Ross,⁶ Martine Gioud-Paquet,^7, Nathalie Dartois,⁷ Evelyn J. Ellis-Grosse,⁸ Evan Loh,⁸ for the Tigecycline 305 cSSSI Study Group

Eugene Marais Hospital, Les Marais, Pretoria, Republic of South Africa,¹ North Estonian Regional Hospital, Clinic of Surgery, Tallinn, Estonia,² P. Stradina Clinical University Hospital, Medical Academy of Latvia, Riga, Latvia,³ Tijger Trial Centre, Karl Bremer and University of Stellenbosch, Bellville, Republic of South Africa,⁴ Tartu University Clinics, Tartu, Estonia,⁵ St. Mary's Hospital, Durban, Republic of South Africa,⁶ Clinical Research and Development, Wyeth Research, Paris, France,⁷ Clinical Research and Development, Wyeth Research, Collegeville, Pennsylvania⁸

Received 13 December 2004/ Returned for modification 7 February 2005/ Accepted 15 August 2005

In a randomized, double-blind, controlled trial, 546 patients with complicated skin and skin structure infections received tigecycline 100 mg/day (a 100-mg initial dose and then 50 mg intravenously twice daily) or the combination of vancomycin 2 g/day (1 g intravenously twice daily) and aztreonam 4 g/day (2 g intravenously twice daily) for up to 14 days. The primary end point was the clinical response in the clinical modified intent-to-treat (c-mITT) and clinically evaluable (CE) populations at the test-of-cure visit 12 to 92 days after the last dose. The microbiologic response at the test-of-cure visit was also assessed. Safety was assessed by physical examination, laboratory results, and adverse event reporting. Five hundred twenty patients were included in the c-mITT population (tigecycline group, n = 261; combination group, n = 259), and 436 were clinically evaluable (tigecycline group, n = 223; combination group, n = 213). The clinical responses in the tigecycline and the combination vancomycin and aztreonam groups were similar in the c-mITT population (84.3% versus 86.9%; difference, –2.6% [95% confidence interval, –9.0, 3.8]; P = 0.4755) and the CE population (89.7% versus 94.4%; difference, –4.7% [95% confidence interval, –10.2, 0.8]; P = 0.1015). Microbiologic eradication (documented or presumed) occurred in 84.8% of the patients receiving tigecycline and 93.2% of the patients receiving vancomycin and aztreonam (difference, –8.5 [95% confidence interval, –16.0, –1.0]; P = 0.0243). The numbers of patients reporting adverse events were similar in the two groups, with increased nausea and vomiting rates in the tigecycline group and an increased incidence of rash and increases in alanine aminotransferase and aspartate aminotransferase levels in the combination vancomycin and aztreonam group. Tigecycline was shown to be safe and effective for the treatment of complicated skin and skin structure infections.

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* Corresponding author. Mailing address: P.O. Box 49223, Hercules, Pretoria, Republic of South Africa 0030. Phone: 27-828256577. Fax: 27-12-4606285. E-mail: jbreedt{at}gpnet.net.

Deceased.

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Antimicrobial Agents and Chemotherapy, November 2005, p. 4658-4666, Vol. 49, No. 11
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.11.4658-4666.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

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