Bacterial Infection Clinical Trial
Official title:
A Randomized, Double-Blind Study Comparing Three Dosing Regimens of Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
The purpose of this study is to determine the safety and efficacy of three different dosing regimens of brilacidin compared to daptomycin for the treatment of serious skin infections. This study will aid in selecting the appropriate dose of brilacidin for later stage studies.
This is a randomized, multi-center, double-blind study to evaluate the efficacy and safety of
three regimens of brilacidin compared to an active control, daptomycin, in subjects with
ABSSSI. Subjects must have infections that warrant intravenous therapy but may be treated as
either inpatients or outpatients.
Eligible subjects will be randomized to one of 4 treatment groups in a 1:1:1:1 ratio.
Subjects randomized to brilacidin will receive either a single intravenous infusion (0.6
mg/kg or 0.8 mg/kg) followed by six days of once daily placebo, or a three day regimen (0.6
mg/kg on Day 1 followed by 0.3 mg/kg on Days 2 and 3) followed by 4 days of once daily
placebo. Subjects randomized to daptomycin will receive 7 days of treatment. Subjects will be
assessed for both clinical and microbiologic efficacy 48-72 hours after the first dose of
study drug. After an assessment at Day 7-8, subjects will be again be evaluated for efficacy
at Day 10-14 and via a phone contact at Day 21-28.
Approximately 200 subjects randomized in a 1:1:1:1 ratio to receive one of the three
brilacidin regimens or daptomycin will be evaluable. The primary efficacy outcome, early
clinical response 48-72 hours after the first dose of study drug, will be determined in the
Intent-to treat (ITT) population. Additional efficacy and safety analyses will be performed.
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