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)



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:May 2010
End Date:February 3, 2011

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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

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.

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.

Inclusion Criteria:

- Male or female patients > 18

- Documented acute bacterial skin and skin structure infection

Exclusion Criteria:

- Uncomplicated skin and skin structure infection
We found this trial at
9
sites
Baton Rouge, Louisiana 70808
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Baton Rouge, LA
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Butte, Montana 59701
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Butte, MT
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Chula Vista, California 91911
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Chula Vista, CA
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Columbus, Georgia 31904
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Columbus, GA
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La Mesa, California 91942
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La Mesa, CA
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Lafayette, Louisiana 70503
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Lafayette, LA
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Oceanside, California 92056
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Oceanside, CA
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Savannah, Georgia 31406
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Savannah, GA
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Somers Point, New Jersey 08244
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Somers Point, NJ
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