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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Infection
Communicable Diseases
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014