The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
215
Active Comparator: Daptomycin.
Experimental: PMX-30063
Unnamed facility
Hamilton, Ontario, Canada
Unnamed facility
Chicoutimi, Quebec, Canada
Unnamed facility
Greenfield Park, Quebec, Canada
Unnamed facility
Québec, Quebec, Canada
The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). The primary measure of efficacy will be bacteriologic eradication at end of treatment of S. aureus (either Methicillin-susceptible (MSSA) or Methicillin-resistant (MRSA)) in subjects with ABSSSI and having S. aureus isolated from an appropriate infection site prior to randomization. The secondary objectives are clinical responses, safety and pharokinetics of PMX-300063.
Time frame: Eradication at end of treatment (day 7/8)
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Unnamed facility
Sherbrooke, Quebec, Canada
Unnamed facility
Trois-Rivières, Quebec, Canada
11 Sites
Multiple, Russia
5 Sites
Multiple, Ukraine