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Open Access Highly Accessed Research article

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections

Peter Matthews1*, Marc Alpert2, Galia Rahav3, Denise Rill4, Edward Zito4, David Gardiner4, Ron Pedersen4, Timothy Babinchak4, Paul C McGovern4 and , for the Tigecycline 900 cSSSI Study Group

Author affiliations

1 Department of Family Medicine, Department of Health, Mpumalanga, Middelburg, 1050, South Africa

2 Central Montgomery Surgical Associates, 1057 South Broad Street, Lansdale, PA, 19446, USA

3 Chaim Sheba Medical Center, Infectious Disease Unit, Tel Hashomer, Ramat Gan, 52621, Israel

4 Pfizer Inc, Collegeville, PA, 19426, USA

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Citation and License

BMC Infectious Diseases 2012, 12:297  doi:10.1186/1471-2334-12-297

Published: 12 November 2012

Abstract

Background

Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.

Methods

In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).

Results

In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.

Conclusions

Tigecycline was generally safe and effective in the treatment of cSSSIs.

Trial registration

ClinicalTrials.gov NCT00368537

Keywords:
Tigecycline; Glycylcycline; cSSSI; Skin and skin structure infection