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)

Phase 2CompletedNCT01119105

Nabriva Therapeutics AG210 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Bacterial Infections Infection

Interventions

BC-3781DRUG

BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

BC-3781DRUG

BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

VancomycinDRUG

Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patients \> 18 * Documented acute bacterial skin and skin structure infection Exclusion Criteria: * Uncomplicated skin and skin structure infection

Locations (9)

BC-3781 Study Center 002

Chula Vista, California, United States

BC-3781 Study Center 001

La Mesa, California, United States

BC-3781 Study Center 003

Oceanside, California, United States

BC-3781 Study Center 012

Outcomes

Primary Outcomes

Clinical Response

Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.

Time frame: Test of Cure (TOC), 7 - 14 days post final treatment

Clinical Response

Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required

Time frame: Test of Cure (TOC), 7 - 14 days post final treatment

Data from ClinicalTrials.gov

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