Title
Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
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
Phase
Phase 2Lead Sponsor
Nabriva Therapeutics AGStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Bacterial Infections InfectionIntervention/Treatment
lefamulin vancomycin ...Study Participants
210This 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.
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.
BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Inclusion Criteria: Male or female patients > 18 Documented acute bacterial skin and skin structure infection Exclusion Criteria: Uncomplicated skin and skin structure infection
| Event Type | Organ System | Event Term | BC-3781 Dose 100mg | BC-3781 Dose 150mg | Vancomycin |
|---|
Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.
Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required
