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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nabriva Therapeutics AG
ClinicalTrials.gov Identifier:
NCT01119105
First received: May 5, 2010
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Infection
Drug: BC-3781
Drug: Vancomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nabriva Therapeutics AG:

Primary Outcome Measures:
  • To assess the clinical response of 2 dose regimens of BC-3781 versus vancomycin over 5 to 14 days when administered as an intravenous infusion twice daily in clinically evaluable patients and modified intent-to-treat population [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: May 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: BC-3781 dose 150mg 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.
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncomplicated skin and skin structure infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119105

Locations
United States, California
BC-3781 Study Center 002
Chula Vista, California, United States, 91911
BC-3781 Study Center 001
La Mesa, California, United States, 91942
BC-3781 Study Center 003
Oceanside, California, United States, 92056
United States, Georgia
BC-3781 Study Center 012
Columbus, Georgia, United States, 31904
BC-3781 Study Center 018
Savannah, Georgia, United States, 31406
United States, Louisiana
BC-3781 Study Center 021
Baton Rouge, Louisiana, United States, 70808
BC-3781 Study Center 023
Lafayette, Louisiana, United States, 70503
United States, Montana
BC-3781 Study Center 004
Butte, Montana, United States, 59701
United States, New Jersey
BC-3781 Study Center 016
Somers Point, New Jersey, United States, 08244
Sponsors and Collaborators
Nabriva Therapeutics AG
Investigators
Study Chair: William T. Prince, Dr. Nabriva Therapeutics AG
  More Information

No publications provided

Responsible Party: Nabriva Therapeutics AG
ClinicalTrials.gov Identifier: NCT01119105     History of Changes
Other Study ID Numbers: NAB-BC-3781-2001
Study First Received: May 5, 2010
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nabriva Therapeutics AG:
acute bacterial skin and skin structure infection
bacteria

Additional relevant MeSH terms:
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014