Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI
The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
716
Proportion of subjects with a response for Early Clinical Response
Proportion of subjects with a response for Early Clinical Response (ECR), defined as alive and achieved ≥ 20% reduction from baseline in the lesion size at 48-72 hours after start of study drug, without receipt of additional non-study antibiotic therapy.
Time frame: 48 to 72 hours after starting treatment
Proportion of subjects with clinical success at Post-treatment Evaluation
Proportion of subjects with clinical success at PTE, in the ITT and clinically evaluable (CE) analysis sets.
Time frame: 7 to 14 days after end of treatment
Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations
Incidence of adverse events, vital sign changes, physical exam changes, and clinical laboratory evaluations will be presented by study arm
Time frame: Up to 24 months
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Anaheim, California, United States
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Bakersfield, California, United States
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Buena Park, California, United States
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Fountain Valley, California, United States
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La Mesa, California, United States
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La Palma, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Modesto, California, United States
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National City, California, United States
...and 52 more locations