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:
Nabriva Therapeutics AG
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 May 16, 2013