Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI
Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Open Label Study to Evaluate the Safety and Efficacy of Tigecycline to Treat Complicated Skin and Skin Structure Infections (cSSSI) in Hospitalized Patients|
- The primary efficacy endpoint will be the clinical response for all clinically evaluable patients (primary population) at the test-of-cure visit
- microbiological response at the patient level microbiological response at the pathogen level clinical cure rates by baseline pathogen response rates for patients with polymicrobial and monomicrobial infections
|Study Start Date:||July 2006|
|Study Completion Date:||August 2007|
To evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.
|Multiple Cities, Taiwan|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|
|Principal Investigator:||Trial Manager||For Taiwan, firstname.lastname@example.org|