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 2

Completed

• Conditions: Bacterial Infections; Infection
• Interventions: Drug: BC-3781; Drug: Vancomycin

• Registration Number: NCT01119105
• Lead Sponsor: Nabriva Therapeutics AG

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-05
• Study First Submitted QC: 2010-05-06
• Study First Posted: 2010-05-07
• Primary Completion: 2010-12-31
• Study Completion: 2011-02-03
• Disposition First Submitted: 2012-06-05
• Disposition First Submitted QC: 2012-06-25
• Disposition First Posted: 2012-07-02
• Status Verified: 2020-10
• Results First Submitted: 2020-10-05
• Results First Submitted QC: 2020-10-05
• Results First Posted: 2020-10-27
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

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Exclusion Criteria

• Uncomplicated skin and skin structure infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BC-3781 dose 150mg	BC-3781	-
BC-3781 dose 100mg	BC-3781	-
Vancomycin	Vancomycin	-

Primary Outcome Measures

Name	Time	Method
Clinical Response	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

Trial Locations

Locations (9)

BC-3781 Study Center 002; 🇺🇸 Chula Vista, California, United States

BC-3781 Study Center 003; 🇺🇸 Oceanside, California, United States

BC-3781 Study Center 012; 🇺🇸 Columbus, Georgia, United States

BC-3781 Study Center 004; 🇺🇸 Butte, Montana, United States

BC-3781 Study Center 021; 🇺🇸 Baton Rouge, Louisiana, United States

BC-3781 Study Center 023; 🇺🇸 Lafayette, Louisiana, United States

BC-3781 Study Center 016; 🇺🇸 Somers Point, New Jersey, United States

BC-3781 Study Center 018; 🇺🇸 Savannah, Georgia, United States

BC-3781 Study Center 001; 🇺🇸 La Mesa, California, United States