Conditions: Bacterial Infections Infection
Keywords: acute bacterial skin and skin structure infection bacteria
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 210
Healthy volunteers: no

Brief summary:
This is a Phase II, multi-center, randomized, double-blind study comparing the safety and efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and skin structure infection.

Detailed description:
The purpose of the study is to determine the efficacy of 2 dose regimens of BC-3781 versus the licensed medicinal product vancomycin over 5 to 14 days. The population in this study will be patients with an acute bacterial skin and skin structure infection (ABSSSI) and they will receive treatment with one of two doses of BC-3781 or vancomycin, a standard treatment for this condition.

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: BC-3781 intervention 2: BC-3781 intervention 3: Vancomycin
Intervention descriptions: intervention 1: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. intervention 2: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response. intervention 3: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Protocol document: