Clinical trial 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Infections
Infection
Keywords: acute bacterial skin and skin structure infection
bacteria
Lead sponsor: Nabriva Therapeutics AG
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Uncomplicated skin and skin structure infection

Primary outcomes:
measure: Clinical Response
timeFrame: Test of Cure (TOC), 7 - 14 days post final treatment
measure: Clinical Response
timeFrame: Test of Cure (TOC), 7 - 14 days post final treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: BC-3781 Study Center 002
state: California
city: La Mesa
country: United States
facility: BC-3781 Study Center 001
state: California
city: Oceanside
country: United States
facility: BC-3781 Study Center 003
state: California
city: Columbus
country: United States
facility: BC-3781 Study Center 012
state: Georgia
city: Savannah
country: United States
facility: BC-3781 Study Center 018
state: Georgia
city: Baton Rouge
country: United States
facility: BC-3781 Study Center 021
state: Louisiana
city: Lafayette
country: United States
facility: BC-3781 Study Center 023
state: Louisiana
city: Butte
country: United States
facility: BC-3781 Study Center 004
state: Montana
city: Somers Point
country: United States
facility: BC-3781 Study Center 016
state: New Jersey
Study officials:
affiliation: Nabriva Therapeutics AG
name: William T. Prince, Dr.
role: STUDY_CHAIR
References:
citation: Rubino CM, Xue B, Bhavnani SM, Prince WT, Ivezic-Schoenfeld Z, Wicha WW, Ambrose PG. Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Jan;59(1):282-8. doi: 10.1128/AAC.02033-13. Epub 2014 Oct 27.