Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

• Drug: Tigecycline
  Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
• Drug: ampicillin-sulbactam

  Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.

  A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.

• Active Comparator: 1
  Arm 1: Tigecycline
  Intervention: Drug: Tigecycline
• Active Comparator: 2
  Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide
  Intervention: Drug: ampicillin-sulbactam

Inclusion Criteria:

• Clinical diagnosis of complicated skin or skin structure infection
• Male or female, 18 years or older
• Need for intravenous treatment for 4 to 14 days

Exclusion Criteria:

• Skin infection that can be treated by surgery & wound care alone
• Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
• Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply