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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)

Primary Purpose

Bacterial Infections, Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BC-3781
BC-3781
Vancomycin
Sponsored by
Nabriva Therapeutics AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring acute bacterial skin and skin structure infection, bacteria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncomplicated skin and skin structure infection

Sites / Locations

  • BC-3781 Study Center 002
  • BC-3781 Study Center 001
  • BC-3781 Study Center 003
  • BC-3781 Study Center 012
  • BC-3781 Study Center 018
  • BC-3781 Study Center 021
  • BC-3781 Study Center 023
  • BC-3781 Study Center 004
  • BC-3781 Study Center 016

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BC-3781 dose 100mg

BC-3781 dose 150mg

Vancomycin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 5, 2010
Last Updated
October 29, 2020
Sponsor
Nabriva Therapeutics AG
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1. Study Identification

Unique Protocol Identification Number
NCT01119105
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
December 31, 2010 (Actual)
Study Completion Date
February 3, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nabriva Therapeutics AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Infection
Keywords
acute bacterial skin and skin structure infection, bacteria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BC-3781 dose 100mg
Arm Type
Experimental
Arm Title
BC-3781 dose 150mg
Arm Type
Experimental
Arm Title
Vancomycin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BC-3781
Intervention Description
BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Intervention Type
Drug
Intervention Name(s)
BC-3781
Intervention Description
BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Primary Outcome Measure Information:
Title
Clinical Response
Description
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
Title
Clinical Response
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William T. Prince, Dr.
Organizational Affiliation
Nabriva Therapeutics AG
Official's Role
Study Chair
Facility Information:
Facility Name
BC-3781 Study Center 002
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
BC-3781 Study Center 001
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
BC-3781 Study Center 003
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
BC-3781 Study Center 012
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
BC-3781 Study Center 018
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
BC-3781 Study Center 021
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
BC-3781 Study Center 023
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
BC-3781 Study Center 004
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
BC-3781 Study Center 016
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25348519
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.
Results Reference
derived

Learn more about this trial

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)

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