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)

Nabriva Therapeutics

Status and phase: Completed; Phase 2

Conditions: Infection; Bacterial Infections

Treatments: Drug: Vancomycin; Drug: BC-3781

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119105

NAB-BC-3781-2001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients > 18
• Documented acute bacterial skin and skin structure infection

Exclusion criteria

• Uncomplicated skin and skin structure infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups

BC-3781 dose 100mg

Experimental group

Treatment:

Drug: BC-3781

Drug: BC-3781

BC-3781 dose 150mg

Experimental group

Treatment:

Drug: BC-3781

Drug: BC-3781

Vancomycin

Active Comparator group

Treatment:

Drug: Vancomycin