Completed
PHASE2
INTERVENTIONAL
NCT01119105
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)
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
BC-3781
Type:
DRUG
Description:
BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Name:
BC-3781
Type:
DRUG
Description:
BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Name:
Vancomycin
Type:
DRUG
Description:
Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Primary Outcomes
Measure:
Clinical Response
TimeFrame:
Test of Cure (TOC), 7 - 14 days post final treatment
Description:
Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.
Measure:
Clinical Response
TimeFrame:
Test of Cure (TOC), 7 - 14 days post final treatment
Description:
Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required
Trial Information
NCT ID
NCT01119105
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Nabriva Therapeutics AG
Last Updated
December 15, 2025