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)

October 29, 2020 updated by: Nabriva Therapeutics AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • BC-3781 Study Center 002
      • La Mesa, California, United States, 91942
        • BC-3781 Study Center 001
      • Oceanside, California, United States, 92056
        • BC-3781 Study Center 003
    • Georgia
      • Columbus, Georgia, United States, 31904
        • BC-3781 Study Center 012
      • Savannah, Georgia, United States, 31406
        • BC-3781 Study Center 018
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • BC-3781 Study Center 021
      • Lafayette, Louisiana, United States, 70503
        • BC-3781 Study Center 023
    • Montana
      • Butte, Montana, United States, 59701
        • BC-3781 Study Center 004
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
        • BC-3781 Study Center 016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncomplicated skin and skin structure infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vancomycin
Drug: Vancomycin
Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Experimental: BC-3781 dose 100mg
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.
Drug: 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.
Experimental: BC-3781 dose 150mg
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response
Time Frame: 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.
Test of Cure (TOC), 7 - 14 days post final treatment
Clinical Response
Time Frame: 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
Test of Cure (TOC), 7 - 14 days post final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabriva Therapeutics AG

Investigators

  • Study Chair: William T. Prince, Dr., Nabriva Therapeutics AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

December 31, 2010

Study Completion (Actual)

February 3, 2011

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 6, 2010

First Posted (Estimate)

May 7, 2010

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAB-BC-3781-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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