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

NCT00368537 Phase 4 COMPLETED Results posted

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).

Details

Lead sponsor	Wyeth is now a wholly owned subsidiary of Pfizer
Phase	Phase 4
Status	COMPLETED
Enrolment	550
Start date	2006-09
Completion	2008-09

Conditions

• Skin Diseases, Bacterial

Interventions

• Tigecycline
• ampicillin-sulbactam

Primary outcomes

• Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit — up to 6 weeks
  Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.

Countries

United States, Canada, Hong Kong, Israel, Lebanon, Malaysia, Philippines, Singapore, South Africa, South Korea, Taiwan, Thailand