title: A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00368537.
authors.affiliation: Department of Family Medicine, Department of Health, Mpumalanga, Middelburg, 1050, South Africa.
authors.forename: Peter
authors.initials: P
authors.lastname: Matthews
authors.forename: Marc
authors.initials: M
authors.lastname: Alpert
authors.forename: Galia
authors.initials: G
authors.lastname: Rahav
authors.forename: Denise
authors.initials: D
authors.lastname: Rill
authors.forename: Edward
authors.initials: E
authors.lastname: Zito
authors.forename: David
authors.initials: D
authors.lastname: Gardiner
authors.forename: Ron
authors.initials: R
authors.lastname: Pedersen
authors.forename: Timothy
authors.initials: T
authors.lastname: Babinchak
authors.forename: Paul C
authors.initials: PC
authors.lastname: McGovern
mesh_terms: D000328:Adult; D000368:Aged; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use*; D000667:Ampicillin / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D012874:Skin Diseases, Infectious / Q000188:drug therapy*; D013407:Sulbactam / Q000009:adverse effects / Q000627:therapeutic use; D000078304:Tigecycline
chemical_list: D000900:Anti-Bacterial Agents; C035444:sultamicillin; D000078304:Tigecycline; D019980:Amoxicillin-Potassium Clavulanate Combination; D000667:Ampicillin; D008911:Minocycline; D013407:Sulbactam