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

BMC Infect Dis. 2012 Nov 12;12:297. doi: 10.1186/1471-2334-12-297.

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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Amoxicillin-Potassium Clavulanate Combination / adverse effects
  • Amoxicillin-Potassium Clavulanate Combination / therapeutic use*
  • Ampicillin / adverse effects
  • Ampicillin / therapeutic use*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Minocycline / adverse effects
  • Minocycline / analogs & derivatives*
  • Minocycline / therapeutic use
  • Skin Diseases, Bacterial / drug therapy*
  • Skin Diseases, Infectious / drug therapy*
  • Sulbactam / adverse effects
  • Sulbactam / therapeutic use
  • Tigecycline

Substances

  • Anti-Bacterial Agents
  • sultamicillin
  • Tigecycline
  • Amoxicillin-Potassium Clavulanate Combination
  • Ampicillin
  • Minocycline
  • Sulbactam

Associated data

  • ClinicalTrials.gov/NCT00368537