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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| ClinicalTrials.gov Identifier: NCT01119105 |
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Recruitment Status :
Completed
First Posted : May 7, 2010
Results First Posted : October 27, 2020
Last Update Posted : November 17, 2020
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Sponsor:
Nabriva Therapeutics AG
Information provided by (Responsible Party):
Nabriva Therapeutics AG
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bacterial Infections Infection | Drug: BC-3781 Drug: Vancomycin | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 210 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Actual Study Start Date : | May 2010 |
| Actual Primary Completion Date : | December 31, 2010 |
| Actual Study Completion Date : | February 3, 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| 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. |
Primary Outcome Measures :
- 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.
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nabriva Therapeutics AG |
| ClinicalTrials.gov Identifier: | NCT01119105 |
| Other Study ID Numbers: |
NAB-BC-3781-2001 |
| First Posted: | May 7, 2010 Key Record Dates |
| Results First Posted: | October 27, 2020 |
| Last Update Posted: | November 17, 2020 |
| Last Verified: | October 2020 |
Keywords provided by Nabriva Therapeutics AG:
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acute bacterial skin and skin structure infection bacteria |
Additional relevant MeSH terms:
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Infections Communicable Diseases Bacterial Infections Skin Diseases, Bacterial Disease Attributes Pathologic Processes Bacterial Infections and Mycoses |
Skin Diseases, Infectious Skin Diseases Vancomycin Lefamulin Anti-Bacterial Agents Anti-Infective Agents |