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
Overview
- Phase
- Phase 2
- Intervention
- BC-3781
- Conditions
- Bacterial Infections
- Sponsor
- Nabriva Therapeutics AG
- Enrollment
- 210
- Locations
- 9
- Primary Endpoint
- Clinical Response
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients \> 18
- •Documented acute bacterial skin and skin structure infection
Exclusion Criteria
- •Uncomplicated skin and skin structure infection
Arms & Interventions
BC-3781 dose 100mg
Intervention: BC-3781
BC-3781 dose 150mg
Intervention: BC-3781
Vancomycin
Intervention: Vancomycin
Outcomes
Primary Outcomes
Clinical Response
Time Frame: Test of Cure (TOC), 7 - 14 days post final treatment
Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required