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)

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119105
• Other study ID #: NAB-BC-3781-2001
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: February 3, 2011

Study information

• Verified date: October 2020
• Source: Nabriva Therapeutics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: February 3, 2011
• Est. primary completion date: December 31, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients > 18

• Documented acute bacterial skin and skin structure infection

Exclusion Criteria:

• Uncomplicated skin and skin structure infection

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Skin Diseases, Bacterial

Intervention

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

Locations

Country	Name	City	State
United States	BC-3781 Study Center 021	Baton Rouge	Louisiana
United States	BC-3781 Study Center 004	Butte	Montana
United States	BC-3781 Study Center 002	Chula Vista	California
United States	BC-3781 Study Center 012	Columbus	Georgia
United States	BC-3781 Study Center 001	La Mesa	California
United States	BC-3781 Study Center 023	Lafayette	Louisiana
United States	BC-3781 Study Center 003	Oceanside	California
United States	BC-3781 Study Center 018	Savannah	Georgia
United States	BC-3781 Study Center 016	Somers Point	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Nabriva Therapeutics AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response	Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.	Test of Cure (TOC), 7 - 14 days post final treatment
Primary	Clinical Response	Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required	Test of Cure (TOC), 7 - 14 days post final treatment