A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections
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
BMC Infectious Diseases 2012, 12:297 doi:10.1186/1471-2334-12-297Published: 12 November 2012
Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.
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).
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.
Tigecycline was generally safe and effective in the treatment of cSSSIs.