This is a randomized, double-blind, double dummy, multicenter Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment
The primary objective is to determine the noninferiority in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with ABSSSI.
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
Oral Linezolid 600 mg twice daily for 10 days
Avellaneda, Pcia Buenos Aires, Argentina
Loma Hermosa, Pcia Buenos Aires, Argentina
Buenos Aires, Argentina
Buenos Aires, Argentina
Córdoba, Argentina
Córdoba, Argentina
Córdoba, Argentina
Paraná, Argentina
Rosario, Argentina
Santa Fe, Argentina