NCT00368537

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Skin Diseases, Bacterial

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2006-08-24
• Last updated: 2012-08-09
• Results posted: 2012-08-09

Locations

57 sites across 12 countries: United States, Canada, Hong Kong, Israel, Lebanon, Malaysia, Philippines, Singapore, South Africa, South Korea, Taiwan, Thailand