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)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Bacterial Infections, Infection

Intervention / Treatment
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* Drug: BC-3781
* Drug: BC-3781
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients > 18 Documented acute bacterial skin and skin structure infection Exclusion Criteria: Uncomplicated skin and skin structure infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute bacterial skin and skin structure infection, bacteria