Official Title: “A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections”

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavutanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: Tigecycline
  • Treatment A: Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
• Drug: ampicillin-sulbactam
  • Ampiciliin-sulbactam: 1.5 g (1 g amplicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) IV every 6 hrs or Amoxicillin-clavulnate: 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 maintainance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with MRSA is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glucopeptide may be discontinued.

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• The primary endpoint will be the clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit.
  • Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s).
    Safety Issue?: No

Secondary Measures

• To compare the microbiologic efficacy of tigecycline with that of the comparator in the microbiologically evaluable(ME)population
  • Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s).
    Safety Issue?: No
• To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cSSSI
  • Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s).
    Safety Issue?: No
• To compare health care utilization between the treatment groups.
  • Time Frame: Clinical response rate (cure/failure rate) 10 to 28 days after the last dose of study antibiotic(s).
    Safety Issue?: No

Inclusion Criteria:

• Clinical diagnosis of complicated skin or skin structure infection
• Male or female, 18 years or older
• Need for intravenous treatment in the hospital 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Wyeth

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368537

Study ID Number: 3074A1-900

ClinicalTrials.gov Identifier: NCT00368537

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration